clinical research project manager

The General Hospital Corporation

<div>Site: The General Hospital Corporation<p></p><p><br>
Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham.</p><br>
<p></p>
The Neurological Clinical Research Institute (NCRI), at the Massachusetts General Hospital (MGH) is a premier Academic Clinical Research Organization (CRO) managing clinical trials in neurological disorders. The NCRI employs physician clinical researchers, research nurses, project managers, data managers, SAS programmers, systems analysts, grants managers, and administrative assistants dedicated to planning and implementing clinical trials.<br>
Reporting to a senior member of the PM team, the Project Manager will be responsible for providing oversight and leadership necessary for the successful delivery of projects from initiation to implementation to close-out of assigned multi-center clinical research activities led by the NCRI. The Project Manager is expected to effectively manage scope, schedule/timelines, budget, quality, and resources of the assigned trial(s). Study management will also include outside clinical site management, vendor management, and study meeting planning and execution.<br>
<br>
PRINCIPAL DUTIES AND RESPONSIBILITIES<br>
Primary Responsibility for the following on assigned studies:<br>
<ul><li>Collaborate with project investigators and research sites to ensure targets are met for study start-up, site activation, patient recruitment, and enrollment.</li><li>Develop/contribute to clinical documents, including protocol and informed consent forms, study manuals, source documentation templates, recruitment materials, and other study tools.</li><li>Work closely with Data Management, Systems, and Biostatisticians to assist with the design of case report forms, study portals, and electronic data capture systems.</li><li>Assist in safety management and reporting to the FDA, Data and Safety Monitoring Boards, medical monitors, funding agencies, and other regulatory bodies.</li><li>Lead cross-functional teams in the timely execution of high-quality clinical research projects, leveraging knowledge, expertise, and risk mitigation while functioning as the principal liaison with key clients, vendors, and internal team members.</li><li>Build effective, high-performance teams via expert communication, decisiveness, and technical expertise.</li><li>Collect, review, and approve all required regulatory documents; and work to ensure the study Trial Master File (TMF) is up to date and &ldquo;audit ready&rdquo; throughout the course of the study.</li><li>Oversee IND/CTA applications and communication with regulatory agencies (FDA, Health Canada, etc.) for studies with investigator-held INDs/CTAs</li><li>Assist project sites with IRB submissions, maintenance of regulatory documents, and responding to study-related questions from sites, vendors, and sponsors in a timely fashion.</li><li>Schedule and develop agendas for project meetings and conference calls.</li><li>Tabulate key metrics for progress reports, help develop presentations for scientific meetings, and assist in preparing publications.</li><li>Prepare presentation materials, such as slide decks, that summarize study progress and efficiency metrics.</li><li>Plan, manage, execute, and participate in all study team meetings, both remote and in person.</li><li>Work closely with the PI/ Sponsor to assist with the management of vendor activities</li><li>Travel to national and international professional meetings as needed.</li><li>Prepare materials including written summaries for internal and external communication (CT.gov, NEALS website, etc) and grant support (funding updates, progress reports, etc).</li><li>Review monitoring plans and tracking, and review of trip reports.</li><li>Work closely with Grants Management on study budget-related questions and invoicing (site payments, vendor contracts, etc).</li></ul><br>
Take on additional tasks and responsibilities, as requested.<br>
<br>
QUALIFICATIONS:<br>
<ul><li>A bachelor&rsquo;s degree is required.</li><li>Minimum of three years of experience working in project management related to clinical research, academic research, or a similar environment required.</li><li>Background/familiarity with biology or other scientific disciplines is preferred, but not required.</li></ul><br>
SKILLS/ABILITIES/COMPETENCIES REQUIRED:<br>
<ul><li>Ability to design, prepare, deliver, and evaluate multicenter clinical studies.</li><li>High level of time management and organizational skills</li><li>Excellent written and verbal communication skills</li><li>Administrative skills to meet regulatory requirements</li><li>Ability to prepare and monitor study budgets</li><li>A solid understanding of clinical research methodology and regulations.</li><li>Sound interpersonal skills and the ability to mentor/supervise others.</li><li>Ability to identify problems and develop potential solutions.</li><li>Experience writing and submitting IRB protocols and knowledge of regulatory processes and regulations is preferred, but not required.</li><li>Excellent computer skills working with Microsoft Office.</li><li>Team player who can work independently in an extremely fast-moving, deadline-driven environment, while balancing multiple tasks simultaneously.</li></ul><br>
WORKING CONDITIONS:<br>
This role has established a long-term and sustainable, structured, flexible workplace program that allows both in-office and off-site work. In-office is standard office conditions. An employee&rsquo;s primary residence is expected during working days for off-site work and must comply with institutional confidentiality requirements. There may be travel on public roads and air travel as needed.<br>
<br>
SUPERVISORY RESPONSIBILITY:<br>
Ability to train and provide oversight &amp; mentoring of clinical trial assistant project manager(s) and staff assistants, as appropriate.<br>
<br>
FISCAL RESPONSIBILITY:<br>
The Clinical Trial Project Manager will assist in study budget preparation and work with the grants management group to monitor study-related expenditures, as appropriate.<p></p><p><b><br>
Job Summary</b></p>
Summary<br>
The position reports directly to the Sr Project Manager and/or Project Director of a large global clinical study. This position has management responsibility for specific roles within a clinical study assigned to support the day-to-day operational project management of assigned trial(s).<br>
<br>
Does this position require Patient Care?<br>
No<br>
<br>
Essential Functions<br>
<ul><li>Collaborating with project investigators and research sites to ensure targets are met for study start up, site activation, patient recruitment and enrollment.
</li></ul><br>
<ul><li>Safety management and reporting to FDA, Data and Safety Monitoring Boards, Medical Monitors, funding agencies and other regulatory bodies.
</li></ul><br>
<ul><li>Collecting, reviewing and approving of all required regulatory documents; and working to ensure the study Trial.
</li></ul><br>
<ul><li>Managing multi-center trials funded by NIH, Industry standards.
</li></ul><br>
<ul><li>Collaborate with grants management team to prepare progress reports.
</li></ul><br>
<ul><li>Provide safety management oversight for studies, in collaboration with study PI and safety boards.</li></ul><p><br>
</p><div><div><div><div><div><div><div><p><b>Qualifications</b></p></div></div></div></div></div></div></div><div>
Education<br>
Bachelor's Degree Related Field of Study required or Master's Degree Related Field of Study preferred<br>
<br>
Can this role accept experience in lieu of a degree?<br>
No<br>
<br>
Licenses and Credentials<br>
<br>
Experience<br>
Progressively more responsible experience in a research related field 3-5 years required and Prior Supervisory Experience 1-2 years preferred<br>
<br>
Knowledge, Skills and Abilities<br>
<ul><li>Strong organizational and communication skills.</li><li>Demonstrated analytical skills.</li><li>Effective problem solving skills.</li><li>Ability to supervise and train staff effectively.</li><li>Strong database management and computer skills.</li><li>Must possess aptitude for budget management.</li></ul></div><p></p><div><div><div><div><div><div><div><p><b><br>
Additional Job Details (if applicable)</b></p></div></div></div></div></div></div></div><p><b>
Physical Requirements</b></p><ul><li>
Standing Frequently (34-66%)</li><li>
Walking Frequently (34-66%)</li><li>
Sitting Occasionally (3-33%)</li><li>
Lifting Frequently (34-66%) 35lbs+ (w/assisted device)</li><li>
Carrying Frequently (34-66%) 20lbs - 35lbs</li><li>
Pushing Occasionally (3-33%)</li><li>
Pulling Occasionally (3-33%)</li><li>
Climbing Rarely (Less than 2%)</li><li>
Balancing Frequently (34-66%)</li><li>
Stooping Occasionally (3-33%)</li><li>
Kneeling Occasionally (3-33%)</li><li>
Crouching Occasionally (3-33%)</li><li>
Crawling Rarely (Less than 2%)</li><li>
Reaching Frequently (34-66%)</li><li>
Gross Manipulation (Handling) Frequently (34-66%)</li><li>
Fine Manipulation (Fingering) Frequently (34-66%)</li><li>
Feeling Constantly (67-100%)</li><li>
Foot Use Rarely (Less than 2%)</li><li>
Vision - Far Constantly (67-100%)</li><li>
Vision - Near Constantly (67-100%)</li><li>
Talking Constantly (67-100%)</li><li>
Hearing Constantly (67-100%)</li></ul><p></p><div><div><div><div><div><div><div><p><b><br>
Remote Type</b></p></div></div></div></div></div></div></div>
Hybrid<p></p><div><div><div><div><div><div><div><p><b><br>
Work Location</b></p></div></div></div></div></div></div></div>
399 Revolution Drive<p></p><div><div><div><div><div><div><div><p><b><br>
Scheduled Weekly Hours</b></p></div></div></div></div></div></div></div>
40<p></p><div><div><div><div><div><div><div><p><b><br>
Employee Type</b></p></div></div></div></div></div></div></div>
Regular<p></p><div><div><div><div><div><div><div><p><b><br>
Work Shift</b></p></div></div></div></div></div></div></div>
Day (United States of America)<p></p><p><b><br>
Pay Range</b></p>
$63,252.80 - $102,596.00/Annual<p></p><p><b><br>
Grade</b></p>
7<br>
<p></p>
At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package.<p></p><div><div><div><div><div><div><div><p><b><br>
EEO Statement:</b></p></div></div></div></div></div></div></div>
1200 The General Hospital Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran&rsquo;s Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at (857)-282-7642.<p></p><h2 class="jobSectionHeader"><b><br>
Mass General Brigham Competency Framework</b></h2><div><div><p>
At Mass General Brigham, our competency framework defines what effective leadership &ldquo;looks like&rdquo; by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.</p></div></div></div>

Clinical Trial Project Manager

Everest Clinical Research

<div><p>Everest Clinical Research (&ldquo;Everest&rdquo;) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.</p>
<p>
Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Everest&rsquo;s headquarters are located in Markham (Greater Toronto Area), Ontario, Canada with additional sites in Bridgewater (Greater New York City Area), New Jersey, USA, Shanghai (Pudong Zhangjiang New District), China and Taipei, Taiwan.</p>
<p>
Everest also recently completed the acquisition of August Research. August Research is a European CRO that provides Clinical Operations and Pharmacovigilance services to a wide variety of pharmaceutical and biotechnology clients. The Company has worked on over 120 projects for Phase I-IV clinical trials across multiple therapeutic areas including cardiovascular, infectious disease, oncology and rare disease. The acquisition of August Research establishes a European footprint for Everest to provide full-service offerings to its pharmaceutical, biotechnology and medical devices clients, and other operational capabilities through the Company&rsquo;s substantive experience and infrastructure across 14 countries in Western and Eastern Europe.</p>
<p>
Everest is known in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients&rsquo; needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success.</p>
<p>
Quality is our backbone, customer-focus is our tradition, flexibility is our strength&hellip;that&rsquo;s us&hellip;that&rsquo;s Everest.</p>
<p>
To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as a <b>Project Manager II</b> for our Bridgewater, New Jersey, USA on-site location, or remotely from a home-based office anywhere in the USA or Canada in accordance with our Work from Home policy.</p>
<p>
The Project Manager II position is accountable for effective and efficient project and portfolio delivery from project start up through closure, ensuring all functional, technical, and financial aspects of the project are being managed effectively and against client and Everest expectations. The project/portfolio management duties include, but are not limited to, establishing the project/portfolio management and tracking foundation for an assigned client, establishing the overall client and service delivery strategy for a given project or group of projects, defining project scope and cost estimate budgets, planning, directing, and controlling project activities, and managing resources and budgets, and project team performance of cross-functional teams engaged in clinical research and development activities. This position is also accountable for reporting project progress status to Everest internal management and its clients, and regular project billing, invoicing, and financial tracking/reporting activities. These activities may include, but are not limited to, managing projects with activities focused on clinical operations, data management, statistics, medical writing, clinical trial technologies (including Interactive Web Response Systems [IWRS]/Interactive Response Technology [IRT] and eDiary/electronic Patient Reported Outcome [ePRO]), administration of data monitoring and adjudication committees, and preparation of drug submissions to regulatory agencies.</p>
<p>
When required, the incumbent may assist the organization in responding to and preparing for Request for Information (RFI) and Request for Proposals (RFP), analyzing the study protocol and project parameters, and subsequently developing cost estimate budgets and performing contract administration activities working with senior leaders in Business Operations.</p>
<p>
When required, the incumbent may also lead project management capability development activities, including the development or enhancement of Standard Operating Procedures (SOPs), project management software, project delivery and control process improvement, and training initiatives.</p>
<p><b>
Key Job Accountabilities:</b></p>
<p></p>
<div><ul><li>Drive effective and efficient management of projects with activities focused on one or more of Everest service areas/functional groups: clinical operations, data management, statistics, medical writing, clinical trial technologies (IWRS/IRT and eDiary/ePRO), administration of data monitoring and adjudication committees, and preparation of submissions to regulatory agencies.</li></ul>
<ul><li>With the guidance of project leadership, ensure successful project team mobilization and communication throughout a project&rsquo;s lifespan to ensure and proactively track project milestones, deliverables, and overall success. This includes, but is not limited to, the following:
<ul><li>Integrate information to develop project budgets for each in-scope service and develop and maintain cross-functional project work plans, including identification of resource requirements and utilization, and deliverable timelines.</li>
<li>Prepare for and facilitate project kick-off meetings (internal and external, as applicable), ensuring dissemination of key project assumptions and information to relevant stakeholders.</li>
<li>Implement project management tools required to ensure accurate tracking and transparency around project progress, expectations, and stakeholders. This may include project communication plans, risk mitigation strategies, statistics and programming tracking sheets, and etc.</li>
</ul></li></ul><ul><li>Lead all project management aspects of assigned Phase I to IV clinical trials and in accordance with ICH guidelines, FDA, Health Canada, EMA, and other applicable regulatory and legal requirements. This includes, but is not limited to, the following:</li></ul>
</div><ul><li>Schedule and conduct project meetings (internal and external), communicate assignments, priorities, and expectations to project team members (across functional groups), and track completion of project deliverables to ensure quality and timeliness of all project-related tasks. This includes preparation of, with the support of key functional stakeholders, meeting agendas and minutes. In some cases, meeting minutes may be delegated to an Associate Project Manager or designee. This also includes scheduling and tracking of core project-specific training (e.g., protocol training).</li>
<li>Is expected to be the primary point-of-contact for clinical trial Sponsors to ensure the timely initiation of any Sponsor-requests that pertain to active clinical projects.</li>
<li>Coordinate activities across functional project teams. Manage the planning, implementation, conduct, and reporting of assigned projects within the established timelines and budgets, and with the quality required by Everest and general industry regulatory standards. Coordinate activities between Everest and trial Sponsors and with various supporting groups or third party vendors (e.g., central laboratory and other specialty laboratories) to ensure that all contractual obligations are met and that any interdependent activities are coordinated effectively and timelines planned for accordingly (e.g., third party vendor data transfers are planned for appropriately in the biostatistics and programming delivery timelines).</li>
<li>Proactively track and manage project tasks against timelines and hours spent/budgets. Prepare project status and progress reports, maintaining accurate and current details for communication to internal and potentially external stakeholders. Alert management when there are risks of having major deviations.</li>
<li>Proactively track and manage the financial status against work order budgets, hours spent, and tasks performed; reconcile expenses across sub-streams of activities (e.g., project attrition reports). This includes monitoring to readily identify out-of-scope tasks and potential need for Change Orders, under the guidance of management/project leaders.</li>
<li>Review and report on overall client portfolio performance (i.e., project delivery, quality, financial performance) and work with senior Project Management leaders to identify areas of opportunities and challenges to define continuous improvement plans.</li>
<li>Generate new sales leads by developing trust-based relationships with client counterparts, with the goal of winning repeat and new business based on client relationships established. Identify opportunities to offer additional Everest services to grow an existing client account.</li>
<li>Function as leading facilitator of problem solving and conflict resolution, working with functional leaders to drive strategic and effective decisions and plans.</li>
<li>Communicate project action items and key decisions through timely minutes and follow up actions.</li>
</ul><div><ul><li>Support general operational and capability building activities for the Project Management department. These include, but are not limited to, the following:</li></ul>
</div><ul><li>Assist in the development and/or revision of training materials, SOPs, technology enablement, and creation of templates and work instructions to develop standardization and streamlined approaches within the Project Management functional group.</li>
<li>Manage and support the establishment and maintenance of project information repositories to support Everest business analytics.</li>
<li>Work with Business Operations leaders to help lead assigned Business Development initiatives, including, but not limited to, the following:
<ul><li>Organize and coordinate responses to and preparation for RFI and RFP across different functional groups, which includes tracking and supporting the completion of:</li>
</ul></li><li>Cost estimates by engaging respective functional group leaders and Business Development Team.</li>
<li>Proposal Development and writing, through the engagement of respective functional group leaders and compilation of key information and project assumptions to ensure quality and accuracy of proposal content.</li>
<li>Support bid defense preparation, including materials development (e.g., presentation slides).</li>
<li>Support contract development, including Service Work Orders, Change Orders, and any other project-specific contracts.</li>
</ul>
<p><b>Qualifications and Experience</b></p>
<div>
<ul><li>Bachelor of Science or Master of Science in life sciences or health related field.</li></ul>
<ul><li>Minimum of 8 years of clinical research experience within a pharmaceutical, biotechnology, or contract research organization setting.</li></ul>
<ul><li>Experienced as a clinical trial monitor; initiating, monitoring, and closing out clinical trials will be desirable for Clinical Operations support tasks.</li></ul>
<ul><li>Ability to travel a maximum of 50% of working hours may be required.</li></ul>
<ul><li>Demonstrated understanding of cross-functional processes including clinical operations, statistics, data management, subject randomization and drug supply management, data monitoring and adjudication committees, regulatory affairs, and medical writing.</li></ul>
<ul><li>Knowledge and understanding of ICH guidelines, FDA, Health Canada, and EMA regulations.</li></ul>
<ul><li>Ability to define scopes and estimate budgets and plan and manage projects, including resource requirements and utilization, hours spent versus budgets, key deliverables, and timelines.</li></ul>
<ul><li>Demonstrated leadership abilities, including setting goals for others and driving to achieve them in accordance with allocated resources, timelines, and budgets.</li></ul>
<ul><li>Excellent interpersonal, oral, and written communication skills. Demonstrated strong negotiation and presentation skills.</li></ul>
<ul><li>Strong ability in problem-solving, including conflict resolution.</li></ul>
<ul><li>Fluency in French, including medical and scientific terminology, will be desirable.</li></ul></div><br>
<p></p>
<p>
To find out more about Everest Clinical Research and to review other opportunities, please visit our website at www.ecrscorp.com</p>
<p>
We thank all interested applicants, however, only those selected for an interview will be contacted.</p>
<p>
Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process.</p>
<p>
#LI-Remote</p></div>

Project Manager II

<div>Site: The General Hospital Corporation<p></p><p><br>
Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham.</p><br>
<p></p>
The Neurological Clinical Research Institute (NCRI) at the Massachusetts General Hospital (MGH) is a premier Academic Research Organization (ARO) managing clinical trials in neurological disorders. The NCRI employs physician clinical researchers, research nurses, project managers, data managers, SAS programmers, systems analysts, grants managers, research nurses, quality specialists, and administrative assistants dedicated to planning and implementing clinical trials.<br>
<br>
The Quality Assurance Clinical Trial Project Manager (QAM) will focus on regulatory and quality assurance aspects of clinical research. Receiving general direction from the NCRI Director Quality Assurance (QA) and QAM II, the QAM is responsible for implementing quality initiatives outlined in the NCRI Quality Management Plan (QMP) and ensuring NCRI staff are conducting research projects according to the QMP, regulations, good clinical practice guidelines, and institutional policies and procedures.<br>
<br>
The incumbent will audit clinical research projects coordinated by NCRI ARO. In addition, the QAM will support the Director of QA during inspections/audits of NCRI performed by regulatory agencies and industry sponsors. The QAM will perform internal reviews of NCRI staff adherence to written policies and procedures. The QAM will draft and revise NCRI policies and standard operating procedures (SOPs).<br>
<br>
PRINCIPAL DUTIES AND RESPONSIBILITIES:<br>
Relevant activities include, but are not limited to the following:
<br>
<ul><li>Implement specific tasks as outlined in the NCRI Quality Management Plan, which defines QA functions, objectives, tracking processes, action plans, and identifies goals.</li><li>Prepare for and participate in external audits of NCRI by regulatory authorities and industry sponsors.</li><li>Lead/assist with drafting responses to audit findings by external auditors.</li><li>Perform on-site and remote site audits and draft audit reports with observations and follow-up action items.
</li><li>Perform internal reviews of NCRI staff adherence to written policies and procedures.</li><li>For assigned projects, review project-related documents to ensure adherence with institutional policies and procedures, GCP and regulations, including protocols, trial master file plans, training plans, quality management plans, etc.
</li><li>Develop new/revise NCRI written procedures, such as policies and SOPs.</li><li>In collaboration with Functional Teams, select and manage vendors contracted by NCRI.
</li><li>Assist with pre-qualification and periodic audits of vendors contracted by NCRI.</li><li>Engage in deviation management activities at the system-level and protocol-level.</li><li>Collaborate with NCRI study teams to build, maintain, and audit Trial Master Files (TMF).</li><li>For assigned projects, develop and implement a risk review program.</li><li>Develop and review corrective action and preventive action plans (CAPAs) and perform effectiveness checks.</li><li>Collaborate with Functional Teams and QAM II on process improvement initiatives for inspection readiness following internal reviews, external audits/inspections, and have effective communication with NCRI ARO leadership and Sponsors.
</li><li>Act as a resource to NCRI staff and provide guidance/advice on regulatory compliance and good clinical practices, as needed.</li><li>Accept responsibilities for special projects as requested.</li></ul><br>
SKILLS AND COMPETENCIES:<br>
<ul><li>High level of time management and organizational skills.</li><li>Excellent leadership, written and verbal communication skills.</li><li>A solid understanding of clinical research methodology and regulations, including FDA, OHRP, and ICH guidelines and regulations related to the conduct of clinical research trials, and the ability to advise study teams on how best to implement these regulations.</li><li>Ability to identify problems and develop potential solutions.</li><li>Excellent computer skills working with Microsoft Office.</li><li>Team player who can work independently in an extremely fast-moving, deadline-driven environment, while balancing multiple tasks simultaneously.</li><li>Ability to make independent, effective decisions.</li><li>The ability to develop and manage positive relationships with sponsor representatives, study team members, and vendors.</li></ul><br>
EXPERIENCE:<br>
Required:<br>
<ul><li>Minimum of three (3) years of working experience related to clinical research, academic research, quality assurance, or a similar environment required.
</li></ul><br>
Preferred:
<br>
<ul><li>Background/familiarity with biology or other scientific disciplines is preferred, but not required.</li><li>Experience with Quality Assurance in a clinical research setting is preferred, but not required.</li><li>Previous experience in quality auditing, both internal and external, is preferred, but not required.
</li></ul><br>
WORKING CONDITIONS:<br>
This position can be either hybrid or remote. Must have reliable internet access. On occasion and at the discretion of the Director of QA, the QAM may be required to be on-site for meetings, sponsor audits, or regulatory inspections. Advanced notice will be given.<br>
<br>
Will travel on public roads and air travel as needed. On occasion, the QAM may be required to travel within the United States to audit investigational sites at the discretion of the Director of QA<p></p><p><b><br>
Job Summary</b></p>
Summary<br>
The position reports directly to the Sr Project Manager and/or Project Director of a large global clinical study. This position has management responsibility for specific roles within a clinical study assigned to support the day-to-day operational project management of assigned trial(s).<br>
<br>
Does this position require Patient Care?<br>
No<br>
<br>
Essential Functions<br>
<ul><li>Collaborating with project investigators and research sites to ensure targets are met for study start up, site activation, patient recruitment and enrollment.
</li></ul><br>
<ul><li>Safety management and reporting to FDA, Data and Safety Monitoring Boards, Medical Monitors, funding agencies and other regulatory bodies.
</li></ul><br>
<ul><li>Collecting, reviewing and approving of all required regulatory documents; and working to ensure the study Trial.
</li></ul><br>
<ul><li>Managing multi-center trials funded by NIH, Industry standards.
</li></ul><br>
<ul><li>Collaborate with grants management team to prepare progress reports.
</li></ul><br>
<ul><li>Provide safety management oversight for studies, in collaboration with study PI and safety boards.</li></ul><p><br>
</p><div><div><div><div><div><div><div><p><b>Qualifications</b></p></div></div></div></div></div></div></div><div>
Education<br>
Bachelor's Degree Related Field of Study required or Master's Degree Related Field of Study preferred<br>
<br>
Can this role accept experience in lieu of a degree?<br>
No<br>
<br>
Licenses and Credentials<br>
<br>
Experience<br>
Progressively more responsible experience in a research related field 3-5 years required and Prior Supervisory Experience 1-2 years preferred<br>
<br>
Knowledge, Skills and Abilities<br>
<ul><li>Strong organizational and communication skills.</li><li>Demonstrated analytical skills.</li><li>Effective problem solving skills.</li><li>Ability to supervise and train staff effectively.</li><li>Strong database management and computer skills.</li><li>Must possess aptitude for budget management.</li></ul></div><p></p><div><div><div><div><div><div><div><p><b><br>
Additional Job Details (if applicable)</b></p></div></div></div></div></div></div></div><p><b>
Physical Requirements</b></p><ul><li>
Standing Frequently (34-66%)</li><li>
Walking Frequently (34-66%)</li><li>
Sitting Occasionally (3-33%)</li><li>
Lifting Frequently (34-66%) 35lbs+ (w/assisted device)</li><li>
Carrying Frequently (34-66%) 20lbs - 35lbs</li><li>
Pushing Occasionally (3-33%)</li><li>
Pulling Occasionally (3-33%)</li><li>
Climbing Rarely (Less than 2%)</li><li>
Balancing Frequently (34-66%)</li><li>
Stooping Occasionally (3-33%)</li><li>
Kneeling Occasionally (3-33%)</li><li>
Crouching Occasionally (3-33%)</li><li>
Crawling Rarely (Less than 2%)</li><li>
Reaching Frequently (34-66%)</li><li>
Gross Manipulation (Handling) Frequently (34-66%)</li><li>
Fine Manipulation (Fingering) Frequently (34-66%)</li><li>
Feeling Constantly (67-100%)</li><li>
Foot Use Rarely (Less than 2%)</li><li>
Vision - Far Constantly (67-100%)</li><li>
Vision - Near Constantly (67-100%)</li><li>
Talking Constantly (67-100%)</li><li>
Hearing Constantly (67-100%)</li></ul><p></p><div><div><div><div><div><div><div><p><b><br>
Remote Type</b></p></div></div></div></div></div></div></div>
Hybrid<p></p><div><div><div><div><div><div><div><p><b><br>
Work Location</b></p></div></div></div></div></div></div></div>
399 Revolution Drive<p></p><div><div><div><div><div><div><div><p><b><br>
Scheduled Weekly Hours</b></p></div></div></div></div></div></div></div>
40<p></p><div><div><div><div><div><div><div><p><b><br>
Employee Type</b></p></div></div></div></div></div></div></div>
Regular<p></p><div><div><div><div><div><div><div><p><b><br>
Work Shift</b></p></div></div></div></div></div></div></div>
Day (United States of America)<p></p><p><b><br>
Pay Range</b></p>
$63,252.80 - $102,596.00/Annual<p></p><p><b><br>
Grade</b></p>
7<br>
<p></p>
At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package.<p></p><div><div><div><div><div><div><div><p><b><br>
EEO Statement:</b></p></div></div></div></div></div></div></div>
1200 The General Hospital Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran&rsquo;s Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at (857)-282-7642.<p></p><h2 class="jobSectionHeader"><b><br>
Mass General Brigham Competency Framework</b></h2><div><div><p>
At Mass General Brigham, our competency framework defines what effective leadership &ldquo;looks like&rdquo; by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.</p></div></div></div>

Quality Assurance Manager

Fortrea

<div><p><b>We are currently seeking an experienced Global Start Up Project Manager with 3+ years of SUPM experience to join our team!
</b></p><p><b>Job Overview:</b></p><p>
Accountable for execution and oversight of local operational clinical trial activities and has ownership, oversight and impact on local regulatory and financial compliance, at a country operations level at the client. The position has a significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up. The ability to indirectly influence investigators, vendors, external partners, and country managers to deliver these commitments is a must. This includes adhering to budget targets and agreed payment timelines, addressing and resolving issues, maintaining expertise in country-based regulations, laws and procedures with minimal support from the client management. The position requires skilled knowledge of budget and contract negotiations, the local ethics, legislation and regulatory environment, submission and approval processes, development of local Informed Consent as well as other site ready and ongoing study deliverables. The position requires the ability to proactively develop risk management and mitigation plans in the country and resolve issues locally.</p><p></p><p><b>
Summary of Responsibilities:</b></p><ul><li>
Ownership of country and site budgets.</li><li>
Development, negotiation, and execution of Clinical Trial Research Agreements (CTRA).</li><li>
Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value.</li><li>
Oversight and tracking of clinical research-related payments.</li><li>
Payment reconciliation at study close-out.</li><li>
Oversight of FCPA, Denied Parties Screening and maintenance of financial systems.</li><li>
Financial forecasting and tracking of operational budget in conjunction with the client manager.</li><li>
Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols. o Development of local language materials including local language Informed Consents and translations. o Works in partnership with IRB/IEC and Regulatory Authority in submission and approval related interactions for assigned protocols.</li><li>
Deliver expertise in country-based regulations, laws, and procedures. o Provide an oversight and tracking of clinical research-related payments.</li><li>
Overlook payment reconciliation at study close-out.</li><li>
Responsible for managing country deliverables, timelines, and results for assigned protocols to meet country commitments.</li><li>
Contributes to the development of local SOPs.</li><li>
May oversee contract workers and local vendors as applicable.</li><li>
Works in close collaboration internally with Clinical country operations (CRD, CRM, CTC, CRA), Country Quality Manager (CQM), Finance, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Business Compliance, Legal and regional operations, Head Quarter functional areas and externally with vendors and sites, IRB/IECs and Regulatory Authorities to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones.</li><li>
Collaborates closely with Regional Operations to align country timelines for assigned protocols. Provides support and oversight to local vendors as applicable.</li><li>
Oversight and coordination of local processes and SOPs. o Responsible for clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management.</li><li>
Enters and updates country information in clinical, regulatory, safety and finance systems.</li><li>
And all other duties as needed or assigned.</li></ul><p></p><p><b>
Qualifications (Minimum Required):</b></p><ul><li>
University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology.</li><li>
In lieu of the above requirement, candidates with a minimum of four (4) or more years of relevant clinical research experience in pharmaceutical or CRO industries or experience in a health care setting will be considered.</li><li>
Fortrea may consider relevant and equivalent experience in lieu of educational requirements.</li><li>
Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries.</li><li>
Thorough understanding of the drug development process.</li><li>
Fluent in local office language and in English, both written and verbal.</li></ul><p></p><p><b>
Experience (Minimum Required):</b></p><ul><li>
Working knowledge of ICH, FDA, local regulatory requirements, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start up documents; previous interaction with operational project team and investigative sites preferred.</li><li>
Minimum of eight (8) years of clinical research experience and SSU work</li><li>
3+ years of SUPM experience</li><li>
Global submissions experience</li><li>
Excellent communication skills, oral and written.</li><li>
Self-motivation with the ability to work under pressure to meet deadlines. Works well independently and in a team environment</li></ul><p></p><p><b>
Preferred Qualifications Include:</b></p><ul><li>
Master or other advanced degree.</li><li>
PMP certification.</li></ul><p></p><p><b>
Physical Demands/Work Environment:</b></p><ul><li><p>
Travel requirements: 20%</p></li></ul><p></p><p><b>
What do you get?</b></p><p></p><p>
Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including but not limited to:</p><ul><li><p>
Medical, Dental, Vision, Life, STD/LTD (multiple insurance carriers)</p></li><li><p>
401(K)</p></li><li><p>
Paid time off (PTO) &ndash; Flex Plan</p></li><li><p>
Employee recognition awards</p></li><li><p>
Multiple ERG&rsquo;s (employee resource groups)</p></li><li><p>
Target Pay Range (based on title): $110 - $130K</p></li></ul><p>
#LI - Remote</p><p>
Applications will be accepted on an ongoing basis.</p><p></p><p><i>
Work Environment:</i></p><ul><li><p><i>
Work is performed in an office environment with exposure to electrical office equipment.</i></p></li><li><p><i>
Frequent travel to clients/ site locations with occasional travel both domestic and international.</i></p></li></ul><p></p><p><i>
Physical Requirements:</i></p><ul><li><p><i>
Ability to sit for extended periods and operate a vehicle safely.</i></p></li><li><p><i>
Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.</i></p></li><li><p><i>
Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.</i></p></li><li><p><i>
Ability to access and use a variety of computer software developed both in-house and off-the-shelf.</i></p></li><li><p><i>
Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.</i></p></li><li><p><i>
Regular and consistent attendance.</i></p></li><li><p><i>
Varied hours may be required.</i></p></li></ul><p></p><p>
Learn more about our EEO &amp; Accommodations request here.</p></div>

Project Manager, Start-Up

Hospital Sisters Health System

<p></p><div><p><b>Pay Range:</b></p>
$28.14 - $42.21<div><div><div><div><div><div><div><p>
A successful candidate's actual pay rate will be based on several factors including relevant experience, skills, training, certifications and education.</p></div></div></div></div></div></div></div><p></p>
HSHS is seeking a PRN-Project Manager-Clinical Trials who has primary responsibility over the management of multiple clinical research trials, to include selection and analysis of potential patients for study participation, obtaining informed consent, documentation of all study required case report forms, identifying potential adverse events and reporting them to FDA/IRB/Study Sponsor as applicable. Ensures that site/principal investigator is compliant with approved protocols. Acts as a liaison between patients, their families and other healthcare professionals during their participation in a research trial.<br>
<br>
Position Specifics:
<br>
Department: Prairie Education and Research Cooperative<br>
Core Function: Nursing<br>
Schedule: PRN<br>
Facility: Springfield - Hollis Building<br>
Location: Springfield, IL
<br>
Compensation that aligns with your experience<br>
<b>Education Qualifications</b><ul><li>
Bachelor&rsquo;s degree in a nursing, science or healthcare related field is required.
</li><li>Master's degree in healthcare, research, business or related discipline is preferred.
</li><li>Associate's degree in radiology plus 3 years of experience special procedures technologist and/or cardiovascular research may be considered in lieu of bachelor's degree.
</li></ul><b>Experience Qualifications</b><ul><li>
2 years healthcare or clinical research experience is required.
</li><li>2 years of experience in research is preferred.
</li></ul><b>Certifications, Licenses and Registrations</b><ul><li>
Healthcare-related license if applicable.
</li><li>Clinical research professional certification (i.e., Certified Clinical Research Coordinator (CCRC) is preferred within 3 years of employment.
</li><li>Human Subject Protection and Good Clinical Practices Training through the Collaborative Institutional Training Initiative (CITI) required within 30 days of hire.
</li></ul>Job Description
<p>Scheduled Weekly Hours:</p>
0<p>
Throughout communities in Illinois and Wisconsin, 13 hospitals, numerous community-based health centers and clinics, our 13,000+ colleagues have built a culture based on our solid core values of respect, care, competence, and joy. These are the ideals we believe in, work by, and live each day.</p><p></p><p>
Built upon more than 145 years of service to the communities we serve, we now look to the future and our place in it as a health care system that strives to continually improve processes, procedures, and outcomes with the latest and most advanced technologies and treatments.</p><p></p><p>
Regardless of how far our passion for excellence carries us, our focus will always remain on the most important person in our entire organization: The patient.</p><p></p><p><b>
Benefits: </b>HSHS provides a benefits package designed to support the overall well-being of our colleagues including their physical, emotional, financial, spiritual, and work health.<b> Colleagues budgeted to work at least 32 hours per pay period are eligible for HSHS benefits.</b></p><ul><li><p>
Comprehensive and affordable health coverage includes medical, prescription, dental and vision coverage for full-time and part-time colleagues.</p></li><li><p>
Paid Time Off (PTO) combines vacation, sick, and personal days into one balance to allow you the flexibility to use your time off as you need.</p></li><li><p>
Retirement benefits including HSHS<br>
contributions.</p></li><li><p>
Education Assistance benefits include up to $5,250 of educational assistance each calendar year and tuition discounts to select colleges with no waiting period.</p></li><li><p>
Adoption Assistance provides financial support up to $7,500 for colleagues growing their families through adoption to reimburse application and legal fees, transportation, and more!</p></li><li><p>
Other benefits include: Wellness program with incentives, employer-paid life insurance and short-term and long-term disability coverage, flexible spending accounts, employee assistance program, ID theft coverage, colleague rewards and recognition program, discount program, and more!</p></li></ul><p></p><p>
Benefits</p><p></p><p>
HSHS and affiliates is an Equal Opportunity Employer (EOE).</p><p></p><p>
HSHS is proud to be an equal opportunity workplace dedicated to pursuing and hiring a diverse workforce.</p></div>

Registered Nurse (RN) Clinical Research Coordinator-PRN

People Science

<p>People Science is looking for a Data Manager to join our team. This is a unique opportunity to be a part of a small team who is looking to empower humanity with the tools and knowledge of science and medicine to improve ourselves, our communities, and our world by making research tools accessible and understandable.</p><p>The People Science proprietary technology, Chloe (Consumer Health Learning &amp; Organizing Ecosystem), is a consumer-friendly mobile app on the frontend, and a modular and configurable clinical research data management tool on the backend. It is designed for the purpose of engaging individual participants in the clinical research process from the comfort of their home by using their personal devices through active and passive data collection.</p><p><b>Job Summary</b><br/>The Data Manager will support the People Science research studies by executing the technical build, configuration, and maintenance of study databases. Reporting to the Senior Data Manager, this role is responsible for the hands-on delivery of data management tasks within the proprietary Chloe Platform. The Data Manager will ensure high standards of data integrity while managing project timelines and deliverables for assigned SaaS and SaaS+ studies.</p><p><b>Duties &amp; Responsibilities</b><br/><b>Data Management &amp; Technical Delivery</b></p><p>● Database Build &amp; Configuration: Execute the end-to-end build, configuration, and validation of study databases within the Chloe Platform based on approved specifications.</p><p>● System Validation: Perform and document User Acceptance Testing (UAT) and validation procedures to ensure database functionality aligns with protocol requirements.</p><p>● Maintenance: Provide ongoing maintenance of study databases, including the implementation of mid-study changes and system updates under the guidance of the Senior Data Manager.</p><p>● Documentation: Develop and maintain key study documentation, including Chloe build specifications, Edit Check Specifications, and Case Report Forms (CRFs).</p><p>● Data Integrity: Monitor incoming data for completeness and accuracy; identify data discrepancies and work with clinical teams to facilitate resolution.</p><p><b>Project Management &amp; Operations</b></p><p>● Project execution: Support the end-to-end execution of SaaS and SaaS+ study types, from initial hand-off through to study closeout. Manage the day-to-day operations of assigned studies to ensure deliverables are met according to the project plan and established timelines.</p><p>● Status Tracking: Track and report on study status, progress, and metrics to internal and external stakeholders.</p><p>● Compliance: Ensure all data management activities are conducted in compliance with SOPs, study protocols, and clinical research regulations.</p><p>● Meeting Support: Assist in preparing materials for client meetings and participate in Clinical Operations activities to ensure study alignment.</p><p><b>Cross-Functional Collaboration</b></p><p>● Internal Liaison: Coordinate with clinical operations and technology teams to ensure a seamless workflow within the Chloe Platform.</p><p>● Requirement Translation: Support the translation of client study objectives into specific technical configurations within the platform.</p><p>● Training Support: Assist in the development of study-specific workflows and help provide platform training to internal and external users.</p><p><b>Requirements and Skills</b></p><p>● Bachelor&rsquo;s degree in life sciences, data sciences, health sciences, or related field or equivalent work experience, preferred</p><p>● 3+ years of experience in clinical data management, ideally in decentralized studies</p><p>● Hands-on experience using clinical trial management systems (CTMS), EDC, or DCT platforms</p><p>● Knowledge of clinical research and clinical study processes</p><p>● Knowledge of GCP, FDA regulations, and ICH guidelines</p><p>● Strong organizational and communication skills, with a &ldquo;tech-savvy&rdquo; mindset, comfortable in a fast-paced environment</p><p><b>Preferred Skills</b></p><p>● Experience with decentralized and virtual study tools (eConsent, ePRO, eSource)</p><p>● Familiarity with User Acceptance Testing and software validation</p><p>● Demonstrated Project Management experience running multiple projects/studies at a time with high attention to detail</p><p><i>*VISA Sponsorship is NOT Available for this position.</i></p><p>We are a remote-first team, primarily based in the Los Angeles area.</p><p>Salary will depend on various factors including applicant's prior relevant job experience, skill set, and geographic location. People Science offers a benefit package for full-time employees which includes: Medical, Dental, Vision, Flexible Spending Account, Life Insurance, DepCare FSA, Flexible Vacation Time Policy, Holidays, Retirement saving opportunity, and Employee Stock Options. People Science reserves the right to amend, change, alter, and revise pay ranges and benefits offerings at any time. It is at the Company's discretion to determine what pay is provided to a candidate within the range associated with the role.</p><p><b>Who We Are</b><br/>www.peoplescience.health<br/>People Science is a direct-to-consumer scientific research company providing a scaled R&amp;D platform for alternative medicines. It is poised to revolutionize the alternative medicine landscape by empowering patients, consumers, providers, and scientists to collectively make discoveries using our research platform. We aim to be the leading tech-enabled research organization in this space. People Science is powered by our proprietary software technology called Chloe (Consumer Health Learning and Organizing Ecosystem), a consumer-friendly mobile app on the frontend, and a modular and configurable clinical research data management tool on the backend. Chloe is a cloud-based modular software platform built to make scaled clinical evidence generation easier and more affordable. It is designed for the purpose of engaging individual participants in the clinical research process by using their personal devices through active and passive data collection. People Science is building an infrastructure and science service model with long term value to humanity. We offer Chloe technology licensing as well as end-to-end clinical research services focusing on cannabinoids, microbiome interventions, supplements and nutraceuticals, natural and synthetic psychedelics, nutrition and &ldquo;food as medicines&rdquo;, and digital health solutions.</p><p>Job Type: Full-time</p><p>Pay: $80,000.00 - $115,000.00 per year</p><p>Benefits:</p><ul><li>Dental insurance</li><li>Flexible spending account</li><li>Health insurance</li><li>Life insurance</li><li>Paid time off</li><li>Retirement plan</li><li>Vision insurance</li></ul><p>Application Question(s):</p><ul><li>What clinical trial management systems do you have hands-on experience with? </li></ul><p>Education:</p><ul><li>Bachelor's (Required)</li></ul><p>Experience:</p><ul><li>clinical data management: 3 years (Required)</li></ul><p>Work Location: Remote</p>

Data Manager (Clinical Research)

<div>Site: The General Hospital Corporation<p></p><p><br>
Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham.</p><br>
<p></p>
The Neurological Clinical Research Institute (NCRI) at the Massachusetts General Hospital (MGH) is a premier Academic Clinical Research Organization (CRO) managing clinical trials in neurological disorders. The NCRI employs physician clinical researchers, research nurses, project managers, data managers, SAS programmers, systems analysts, grants managers, and administrative assistants dedicated to planning and implementing clinical trials.
<br>
<br>
Reporting to a senior member of the PM team, the Assistant Project Manager will be responsible for assisting the Project Manager in providing oversight and leadership necessary for the successful delivery of projects from initiation to implementation to close-out of assigned multi-center clinical research activities led by the NCRI. The Assistant Project Manager is expected to assist the Project Manager in effectively managing the scope, schedule/timelines, budget, quality, and resources of the assigned trial(s). The Assistant Project Manager will also assist the Project Manager in study management, including outside clinical site management, vendor management, and study meeting planning and execution.<br>
<br>
PRINCIPAL DUTIES AND RESPONSIBILITIES:<br>
Responsible for tasks relevant to the scope of assigned projects:
<br>
<ul><li>Collaborating with project investigators and research sites to ensure targets are met for study start-up, site activation, patient recruitment, and enrollment.</li><li>Developing study documents including protocol and informed consent forms, study manuals, source documentation templates, recruitment materials, and other study tools.</li><li>Working closely with Data Management, Systems, and Biostatisticians to assist with the design of case report forms, study portals, and electronic data capture systems.</li><li>Safety management and reporting to FDA, Data and Safety Monitoring Boards, Medical Monitors, funding agencies, and other regulatory bodies.</li><li>Leading cross-functional teams in the timely execution of high-quality clinical research studies, leveraging knowledge, expertise, and risk mitigation.</li><li>Building effective, high-performance teams via expert communication, decisiveness, and technical expertise</li><li>Collecting, reviewing, and approving all required regulatory documents; and working to ensure the study Trial Master File (TMF) is up to date and &ldquo;audit ready&rdquo; throughout the course of the study.</li><li>Overseeing IND/CTA applications and communication with regulatory agencies (FDA, Health Canada, etc.) for studies with investigator-held INDs/CTAs.</li><li>Assisting sites with IRB submissions, maintenance of regulatory documents, and responding to study-related questions from sites, vendors, and sponsors in a timely fashion.</li><li>Scheduling and developing agendas and meeting minutes, in collaboration with the study team, for study related meeting &ndash; both remote and in person, and leading meetings/calls as needed.
</li><li>Tabulating key metrics for progress reports, presentations, and assisting in preparing publications.</li><li>Preparing materials, including written summaries for internal and external communication (CT.gov, NEALS website, etc) and grant support (funding updates, progress reports, etc).</li><li>Reviewing monitoring plans and tracking and reviewing trip reports.</li><li>Working closely with Grants Management on study budget-related questions and invoicing (site payments, vendor contracts, etc).</li><li>Working closely with the PI/ Sponsor, assist with the management of vendor activities</li><li>Travel to national and international professional meetings as needed.</li></ul><br>
Escalates issues to the Project Manager responsible for assigned projects, as appropriate<br>
Take on additional tasks and responsibilities, as requested.<br>
<br>
QUALIFICATIONS:<br>
<br>
<ul><li>A bachelor&rsquo;s degree is required.</li><li>At least one year of experience in research or a related field.</li><li>Background/familiarity with biology or other scientific disciplines is preferred, but not required.</li></ul><br>
SKILLS/ABILITIES/COMPETENCIES REQUIRED:<br>
<ul><li>Knowledge of federal regulations relating to the protection of human subjects and good clinical practice guidelines.</li><li>Attention to detail, excellent organizational and analytical skills.
</li><li>Excellent computer skills working with Microsoft Office.</li><li>Team player who can take direction to work independently in an extremely fast-moving, deadline-driven environment, while balancing multiple tasks simultaneously.
</li></ul><br>
WORKING CONDITIONS:<br>
This role has established a long-term and sustainable, structured, flexible workplace program that allows both in-office and off-site work. In-office is standard office conditions. An employee&rsquo;s primary residence is expected during working days for off-site work and must comply with institutional confidentiality requirements. There may be travel on public roads and air travel as needed.<p></p><p><b><br>
Job Summary</b></p>
Summary<br>
Fully knowledgeable of the department/trial(s) protocol requirements, works with a high degree of independence, and contributes to implementing process improvements. By virtue of their experience, expected to provide guidance and mentorship to staff regarding department/trial operations.<br>
<br>
Does this position require Patient Care?<br>
No<br>
<br>
Essential Functions<br>
<ul><li>Manage multiple clinical trial sites for the duration of the trial.
</li></ul><br>
<ul><li>Collect and review essential regulatory documents for completeness before submitting them to Regulatory for final review and/or approval.
</li></ul><br>
<ul><li>Advise research sites on protocol conduct and interpretation, and ensure the resolution of any issues.
</li></ul><br>
<ul><li>Evaluate the quality and timeliness of data entry, issue, track, and resolve queries, and implement corrective action plans as needed.
</li></ul><br>
<ul><li>Maintain a clinical trial database that includes the latest protocol versions and updated contact information.
</li></ul><br>
<ul><li>Work with the department/trial manager(s) to address issues identified through periodic quality monitoring activities and/or audits.
</li></ul><br>
<ul><li>Prepare official trial correspondence (i.e., numbered memos). Develop and maintain databases. Generate reports as needed from internal and external databases.
</li></ul><br>
<ul><li>Assist in the training and development of other junior staff members in key processes and procedures.
</li></ul><br>
<ul><li>Work with the department/trial manager(s) to address issues identified through periodic quality monitoring activities and/or audits.</li></ul><p><br>
</p><div><div><div><div><div><div><div><p><b>Qualifications</b></p></div></div></div></div></div></div></div><div>
Education<br>
Bachelor's Degree Related Field of Study required<br>
<br>
Can this role accept experience in lieu of a degree?<br>
Yes<br>
<br>
Licenses and Credentials<br>
<br>
Experience<br>
Previous Industry Clinical Trial experience 2-3 years required and Data Management experience 2-3 years preferred<br>
<br>
Knowledge, Skills and Abilities<br>
<ul><li>Demonstrated high-level proficiency in MS Office products (Word and Excel) and familiarity with databases.</li><li>Excellent interpersonal, communication, and problem-solving skills, along with attention to detail and follow-through.</li><li>Able to work objectively, exercise discretion, and maintain strict confidentiality.</li><li>Time management skills and the ability to function effectively within a changing environment.</li><li>Solid written and verbal communication skills.</li></ul></div><p></p><div><div><div><div><div><div><div><p><b><br>
Additional Job Details (if applicable)</b></p></div></div></div></div></div></div></div><p><b>
Physical Requirements</b></p><ul><li>
Standing Frequently (34-66%)</li><li>
Walking Frequently (34-66%)</li><li>
Sitting Occasionally (3-33%)</li><li>
Lifting Frequently (34-66%) 35lbs+ (w/assisted device)</li><li>
Carrying Frequently (34-66%) 20lbs - 35lbs</li><li>
Pushing Occasionally (3-33%)</li><li>
Pulling Occasionally (3-33%)</li><li>
Climbing Rarely (Less than 2%)</li><li>
Balancing Frequently (34-66%)</li><li>
Stooping Occasionally (3-33%)</li><li>
Kneeling Occasionally (3-33%)</li><li>
Crouching Occasionally (3-33%)</li><li>
Crawling Rarely (Less than 2%)</li><li>
Reaching Frequently (34-66%)</li><li>
Gross Manipulation (Handling) Frequently (34-66%)</li><li>
Fine Manipulation (Fingering) Frequently (34-66%)</li><li>
Feeling Constantly (67-100%)</li><li>
Foot Use Rarely (Less than 2%)</li><li>
Vision - Far Constantly (67-100%)</li><li>
Vision - Near Constantly (67-100%)</li><li>
Talking Constantly (67-100%)</li><li>
Hearing Constantly (67-100%)</li></ul><p></p><div><div><div><div><div><div><div><p><b><br>
Remote Type</b></p></div></div></div></div></div></div></div>
Hybrid<p></p><div><div><div><div><div><div><div><p><b><br>
Work Location</b></p></div></div></div></div></div></div></div>
399 Revolution Drive<p></p><div><div><div><div><div><div><div><p><b><br>
Scheduled Weekly Hours</b></p></div></div></div></div></div></div></div>
40<p></p><div><div><div><div><div><div><div><p><b><br>
Employee Type</b></p></div></div></div></div></div></div></div>
Regular<p></p><div><div><div><div><div><div><div><p><b><br>
Work Shift</b></p></div></div></div></div></div></div></div>
Day (United States of America)<p></p><p><b><br>
Pay Range</b></p>
$63,252.80 - $102,596.00/Annual<p></p><p><b><br>
Grade</b></p>
7<br>
<p></p>
At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package.<p></p><div><div><div><div><div><div><div><p><b><br>
EEO Statement:</b></p></div></div></div></div></div></div></div>
1200 The General Hospital Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran&rsquo;s Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at (857)-282-7642.<p></p><h2 class="jobSectionHeader"><b><br>
Mass General Brigham Competency Framework</b></h2><div><div><p>
At Mass General Brigham, our competency framework defines what effective leadership &ldquo;looks like&rdquo; by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.</p></div></div></div>

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