clinical trial manager

Blood Cancer United

How many people can answer the question, "What do you do for a living?" with the answer, "I help find cures for cancer." At Blood Cancer United, employees take our mission seriously. Whether you work in one of our regions, are an accountant at the national office or a specialist in our Information Resource Center, you work each day on making our bold goal a reality: to enable patients with blood cancer to gain more than one million years of life by 2040. Join us and give new meaning to the word, "job."
<br><b>Overview:</b> The PedAL Clinical Trial Manager (CTM) serves as the primary liaison between Blood Cancer United and the Pharmaceutical Clinical Research team, overseeing the successful execution of clinical trials from inception to completion. This role bridges the gap between scientific and operational aspects of clinical research, ensuring projects are carried out efficiently, within budget, and in compliance with regulatory standards. The CTM is responsible for leading cross-functional teams to deliver high quality clinical trials that evaluate the safety and effectiveness of pharmaceuticals.
<br><br>
<b>Key Responsibilities:</b><b>Trial Planning and Initiation:</b><br>
<ul>
<li>Support bidding and defense conversations to win clinical trials. Consult with Contract Research Organizations (CROs) on bid strategies, including sites, patient enrollment, and overarching approaches.</li>
<li>Manage and help finalize scope conversations leading to clinical trial contracts.</li>
<li>Contribute to the review and finalization of trial protocols and related documents.</li>
<li>Establish and maintain successful collaborations with customers, CROs, third-party vendors, study investigators, and site research personnel.</li>
<li>Create comprehensive project plans (e.g., using SmartSheet, Excel, or other software) and build realistic timelines.</li>
<li>Assess and recommend study vendors.</li>
</ul>
Trial Execution and Management
<br><ul>
<li>Establish and maintain Blood Cancer United study file to ensure that key study documents are accessible when needed.</li>
<li>Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional policies.</li>
<li>Proactively identify potential delays and out-of-scope work.</li>
<li>Implement proactive and reactive study challenge mitigations to keep trials on track.</li>
<li>Participate in proactive identification, assessment, and management of clinical study risks.</li>
<li>Identify issues and communicate and/or escalate to the appropriate leadership channels</li>
<li>Provide study updates and report on study metrics to study governance committees</li>
<li>Facilitate strategic decisions to optimize implementation of projects specific to the management of scope, financials, and schedules.</li>
<li>Ensure that records of study activity, including case report forms, drug dispensation records, and regulatory forms, are maintained.</li>
<li>Motivate team members and investigators toward trial goals.</li>
<li>Ensure all study communication and documentation is filed in the Trial Master File.</li>
</ul>
Stakeholder Management
<br><ul>
<li>Maintain constant communication with pharmaceutical partners to ensure client satisfaction and study team improvement.</li>
<li>Conduct regular status meetings with internal teams and external partners.</li>
<li>Develop budgets and additional timelines that are realistic yet aggressive.</li>
<li>Prepare and deliver periodic updates to BCU leadership and other internal stakeholders.</li>
<li>Collaborate on an as-needed basis with the BCU Communications and Constituent Experience teams to develop promotional materials, internal communications, and provide input on website content.</li>
</ul>
Quality and Compliance
<br><ul>
<li>Ensure the clinical project team maintains a continuous state of audit readiness.</li>
<li>Assure compliance with all applicable ICH/GCP, FTC, and FDA regulations, IRB/IEC parameters, and SOPs.</li>
<li>Anticipate project risks and develop mitigation strategies/plans to address complex risk factors.</li>
<li>Review clinical monitoring reports, including Site Initiation Visit reports, Interim Monitoring Visit reports, and Close Out Visit reports.</li>
<li>Support development and maintenance of internal and external clinical study materials, processes, manuals, plans, committees, and other necessary documents.</li>
</ul>
#LI-Remote
<br><br>
<b>Qualifications:</b><b>Education and Experience:</b><br>
<ul>
<li>Bachelor's degree in life sciences, nursing, pharmacy, medical sciences, or related field preferred.</li>
<li>5+ years of clinical research experience (e.g., pharmaceutical, medical device, IVD, biotechnology, CRO), including proven ability to oversee clinical teams in the conduct of multicenter, complex studies. Oncology experience highly preferred.</li>
<li>Certifications such as Certified Clinical Project Manager (CCPM) or Project Management Professional (PMP) are preferred.</li>
</ul>
<b>Required Skills and Competencies:</b><br>
<ul>
<li>Knowledge of clinical trial concepts and practices, including clinical research guidelines.</li>
<li>Knowledge and understanding of project management standards used to develop and maintain integrated project plans.</li>
<li>Strong attention to detail and strong organizational skills.</li>
<li>Ability to track multiple deadlines and budgets.</li>
<li>Team leadership and collaboration abilities.</li>
<li>Excellent communication and interpersonal skills.</li>
<li>Problem-solving and decision-making skills.</li>
<li>Proven ability to work effectively and independently with multi-level teams.</li>
<li>Ability to manage multiple projects in a fast-paced and changing environment.</li>
<li>Demonstrated and effective interpersonal, communications, and negotiation skills for a wide variety of audiences.</li>
</ul>
<b>Employee Value Proposition:</b><br>
As a valued member of Blood Cancer United, you are eligible for a comprehensive benefits package. Our offerings include medical, dental, and vision insurance; life insurance; flexible spending accounts; a 403b retirement plan along with generous paid time off. In addition, we observe federal paid holidays throughout the year, and offer a wellness program and an employee assistance program.
<br><br>
We are excited to share the base pay range for this position is $111K to $120K. The offered compensation may vary based on factors such as geographic location, business need, market conditions, proficiencies, skills, education, and experience. Additionally, at Blood Cancer United we place a high value on internal pay equity and will consider the current compensation of similarly situated roles and direct team members. Base compensation is only one component of our Total Rewards program, which also includes an annual incentive plan and a competitive benefits package.
<br>The statements herein are intended to describe the general nature and level of work being performed by employees, and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of employees. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of the Company. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
<br>Disclaimer
<br>Blood Cancer United is an equal employment opportunity employer committed to diversity and inclusion in its workplace. All qualified applicants will receive consideration for employment without regard to sex, gender, gender identity and expression (including transgender status), sexual orientation, pregnancy, age, race, color, creed, national origin/ancestry, citizenship, religion, genetic predisposition or information, physical or veteran status, or any other characteristic protected by law. Blood Cancer United seeks such skilled and qualified individuals to share our mission and where they will join a cohort of others who have chosen to call Blood Cancer United home. Blood Cancer United complies with all applicable laws which prohibit discrimination and harassment in the workplace, and is committed to maintaining a diverse and inclusive environment supportive of all of our employees and the communities we serve.

Clinical Trial Program 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

<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>

Clinical Trial Assistant Project Manager

The Alfred Foundation

<div>
 <strong>
  Bayside Health
  <br/>
  <br/>
 </strong>
 Bayside Health is a public health service delivering high-quality care across every stage of life for close to 1.2 million people living in metropolitan Melbourne, the Mornington Peninsula, Koo Wee Rup, Bass Coast and Southern Gippsland. We have more than 15 main sites, including hospitals, centres and clinics that provide comprehensive care from welcoming newborns to supporting older people and a full range of services in between. More than 22,000 dedicated staff are focused on providing exceptional, equitable, and locally connected care through shared expertise, compassion, and a commitment to continuous growth. Education and training are central to staff development as we encourage all employees to strive and thrive. Bayside Health was formed following the merger of Alfred Health, Bass Coast Health, Gippsland Southern Health Service, Kooweerup Regional Health Service and Peninsula Health on 1 January 2026.
 <br/>
 <br/>
 <ul>
  <li>
   12-month fixed term role with opportunity for renewal
  </li>
  <li>
   Full time (76 hours per fortnight)
  </li>
  <li>
   Level 2 Research Nurse Grade 3B (YU13) or Medical Scientist Grade 2 (RY4)
  </li>
  <li>
   Located at The Alfred
  </li>
  <li>
   Great staff benefits!
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  The Department
  <br/>
  <br/>
 </strong>
 The Medical Oncology Unit provides co-ordinated multidisciplinary management for adult patients with malignancies. An important component of this care is the Clinical Trial / Research activities we participate in, which enable us to offer forthcoming investigational treatments to our patients.
 <br/>
 <br/>
 Alfred Cancer Trials (ACT) conducts phase I, II and III trials, and is a participating member of both National and International Clinical Trials Groups, incorporating both pharmaceutical industry sponsored and investigator driven studies across a wide range of tumour types.
 <br/>
 <br/>
 <strong>
  The Role
  <br/>
  <br/>
 </strong>
 Trial coordination of allocated clinical trials within the framework of Good Clinical Practice.
 <br/>
 <br/>
 <ul>
  <li>
   Responsible for the delivery of clinical-trial-related care of patients
  </li>
  <li>
   Completing study related procedures and associated documentation
  </li>
  <li>
   Coordinate patient visits and scheduling as per trial requirements and available resources.
  </li>
  <li>
   Maintain good communication with study investigators
  </li>
  <li>
   Liaise with sponsors and clinical research organizations
  </li>
  <li>
   Report Adverse Events and Serious Adverse Events
  </li>
  <li>
   Educate patients and families about trials and patient safety
  </li>
  <li>
   Meet project deadlines and data locks with the direction and support of investigators and trial coordinators
  </li>
  <li>
   Collection of study data, data entry and maintenance of a study database
  </li>
  <li>
   Maintain accurate clinical records and associated clinical research data and site files
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Essential
  <br/>
  <br/>
 </strong>
 <strong>
  Qualifications and Experience Required
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Registered Nurse with the Nursing Midwifery Boad of Australia via AHPRA or Tertiary Medical Science qualification
  </li>
  <li>
   Current and satisfactory Police, and Working with Children checks
  </li>
  <li>
   Relevant post graduate education or progress
  </li>
  <li>
   Well-developed communication and interpersonal skills
   <br/>
   <br/>
  </li>
 </ul>
 <em>
  Desirable
  <br/>
  <br/>
 </em>
 <ul>
  <li>
   Basic understanding of oncology patients and their management
  </li>
  <li>
   Previous clinical trial experience
  </li>
  <li>
   Experience interacting with patients
  </li>
  <li>
   Current GCP certification
  </li>
  <li>
   Demonstrated ability to use clinical trial information systems (CTMS) and electronic case report forms (eCRF)
  </li>
  <li>
   Demonstrated knowledge of professional standards and knowledge of legal and ethical requirements in clinical trials
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Staff Benefits
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Salary packaging &amp; novated leasing through Maxxia
  </li>
  <li>
   Onsite car &amp; bike parking opportunities, deducted pre-tax!! *subject to availability
  </li>
  <li>
   Fantastic onsite fitness facilities at The Alfred through ProSport health and fitness
  </li>
  <li>
   Childcare services at The Alfred managed by KU Children&rsquo;s Services
   <br/>
   <br/>
  </li>
 </ul>
 <em>
  If applicable, please specify specific requirements that you require in your cover letter or CV.
  <br/>
  <br/>
 </em>
 <strong>
  For enquiries regarding this position, please contact Micheleine Uhe, Clinical Research Manager - m.uhe@alfred.org.au
  <br/>
  <br/>
 </strong>
 <strong>
  Applications close 11pm AEDT, Monday 30th March 2026.
  <br/>
  <br/>
 </strong>
 We embrace diversity and strive to have a workforce that reflects the communities we serve. We actively encourage applications from Aboriginal and Torres Strait Islander people, people with disability, and people of all genders, sexualities, and cultural backgrounds.
 <br/>
 <br/>
 If you require adjustments to the recruitment and selection process, or require an alternative format to any of the application materials, please don&rsquo;t hesitate to get in touch with the contact person listed on this ad.
 <br/>
 <br/>
 In accordance with the Health Services Amendment (Mandatory Vaccination of Healthcare Workers) Act 2020, health care workers in Category A or B roles (as determined by the department&rsquo;s risk ratings) are required to be vaccinated against influenza or hold an acceptable medical exemption.
</div>


Clinical Trial Coordinator

ImmunityBio, Inc.

<div>
 <strong>
  Company Overview
  <br/>
  <br/>
 </strong>
 ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient&rsquo;s natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient&rsquo;s immune system and treat the host rather than just the disease.
 <br/>
 <br/>
 Why ImmunityBio?
 <br/>
 <br/>
 <ul>
  <li>
   ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases.
  </li>
  <li>
   Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California.
  </li>
  <li>
   Work with a collaborative team with the ability to work across different areas of the company.
  </li>
  <li>
   Ability to join a growing company with professional development opportunities.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Position Summary
  <br/>
  <br/>
 </strong>
 The Clinical Research Associate, In-House will participate in clinical research teams to ensure the most effective and efficient conduct of clinical research studies by providing training, protocol interpretation, document collection and review and overall clinical trial support.
 <br/>
 <br/>
 <strong>
  Essential Functions
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Review of study-related materials including site initiation training slides, site specific informed consent form templates, procedures and laboratory manuals and development/procurement of applicable appendix documents
  </li>
  <li>
   Interpret medical and scientific intent of assigned study protocols and study procedures, logistics, risks to research subjects, safety, data evaluation methods to support review of study-related materials
  </li>
  <li>
   Track and maintain ImmunityBio study personnel list and training records for assigned studies
  </li>
  <li>
   Communicate study rationale for assigned studies to study team members and clinical sites
  </li>
  <li>
   Support Clinical Trial Manager (CTM) and Clinical Program Manager (CPM) with triage of clinical site inquiries regarding protocol interpretation and eligibility requirements
  </li>
  <li>
   Create/edit site feasibility questionnaire template, track feasibility/start-up activities
  </li>
  <li>
   Create regulatory document templates, oversee and support collection of essential documents during site start-up
  </li>
  <li>
   Review non-investigational product (non-IP) supply list from the CTM for research sample processing and shipment, review non-IP supply orders forms and work with Supply Chain (SC) for distribution to clinical sites
  </li>
  <li>
   File documents to the Trial Master File (TMF) and maintain expected document lists (EDLs) for study and country level documents and provide tracking and/or metrics throughout the study lifecycle as delegated by the CTM
  </li>
  <li>
   Communicate regularly with field Clinical Research Associates (CRAs) during site start-up and provide missing document list before the Site Initiation Visit and as needed for subsequent visits
  </li>
  <li>
   Partner with field CRAs and CTAs to resolve document issues identified during site visits
  </li>
  <li>
   Review investigational product (IP) metrics to ensure sites maintain sufficient quantities to properly conduct the trial as well as work with SC to ensure IP temperature monitoring excursions are documented and train or assist sites with corrective actions
  </li>
  <li>
   File documents to the Trial Master File (TMF) and maintain expected document lists (EDLs) for assigned site documents and provide tracking and/or metrics throughout the study lifecycle
  </li>
  <li>
   File documents to the TMF on behalf of functional groups that do not have access to the TMF as needed
  </li>
  <li>
   Perform content review and post approval review of documents filed to the TMF
  </li>
  <li>
   Provide approved study manuals and form templates to clinical sites in anticipation of Site Initiation Visit
  </li>
  <li>
   Support training of suppliers, investigators, and study coordinators on study requirements and provide guidance on site issues
  </li>
  <li>
   Conduct clinical specimen log review, track and coordinate shipment of specimens to the sponsor or contracted supplier
  </li>
  <li>
   Train sites on specimen and shipment requirements for central laboratory and serve as liaison with contracted suppliers, create and manage site shipping accounts
  </li>
  <li>
   Support supplier oversight including working with supplier quality group for supplier qualification and new vendor request process with finance and accounting
  </li>
  <li>
   Conduct remote monitoring tasks including reconciliation of site investigational product accountability
  </li>
  <li>
   Audit Investigator/Site invoices for accuracy and reconcile invoices against the case report forms (CRFs) and budget for payment submission, perform invoice reconciliation at site close-out
  </li>
  <li>
   Submit purchase requisitions to Enterprise Resource Planning (ERP) System for Clinical Operations and functional groups as needed. Request invoice approval from internal supplier designee(s).
  </li>
  <li>
   Work with accounting and finance to ensure activated clinical site record is added to the ERP System for site payment processing
  </li>
  <li>
   Provide data listings and compile clinical study report documents to support medical writing activities
  </li>
  <li>
   Create and/or review of slides, overheads, etc., for a project, departmental, sponsor and/or business development presentations
  </li>
  <li>
   Participate in clinical operations safety reporting activities including distribution to sites, tracking, IRB submission, TMF filing and completion of required form for updates to Safety Distribution System for site personnel or site status changes
  </li>
  <li>
   Submit clinical trial documentation to central IRB after initial submission by the CTM as needed
  </li>
  <li>
   Collaborate with other functional groups such as data management, pharmacovigilance, biostatistics etc. to ensure clinical trial activities are documented efficiently, compliant with regulations and standards, and aligned with project objectives
  </li>
  <li>
   Assist CTM with management of trial projects as delegated by the CTM
  </li>
  <li>
   Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Education &amp; Experience
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Bachelor&rsquo;s degree with 4+ year experience as a Clinical Trials Associate (or 7+ years&rsquo; clinical research experience) required; or
  </li>
  <li>
   Associate&rsquo;s degree with 7+ years&rsquo; experience as a Clinical Trials Associate (or 10+ years clinical research experience) required
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Knowledge, Skills, &amp; Abilities
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Proficiency in MS Word, Excel, PowerPoint, Outlook, Adobe
  </li>
  <li>
   Excellent written/oral communication skills
  </li>
  <li>
   Strong organizational and multi-tasking skills
  </li>
  <li>
   Maintain corporate confidentiality at all times
  </li>
  <li>
   Ability to set priorities and independent decision making
  </li>
  <li>
   Ability to work independently as well as in teams
  </li>
  <li>
   Strong oral and written communication skills
  </li>
  <li>
   Outgoing and confident demeanor
  </li>
  <li>
   Independent thinker and persuasive communicator
  </li>
  <li>
   Detail oriented, with solid organization and time management skills
  </li>
  <li>
   Completes projects with reliability and minimal guidance
  </li>
  <li>
   Knowledge of drug development process
  </li>
  <li>
   Computer literacy: EDC, eTMF, CTMS, etc.
  </li>
  <li>
   Working knowledge of ICH E6, and the Code of Federal Regulations
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Working Environment / Physical Environment
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   This position works on site in El Segundo, CA or remotely depending on the geographic location of the candidate
  </li>
  <li>
   Regular work schedule is Monday &ndash; Friday, within standard business hours. Flexibility is available with manager approval.
   <br/>
   <br/>
  </li>
 </ul>
 This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate&rsquo;s qualifications, prior experience as well as geographic location.
 <br/>
 <br/>
 National Market (all markets unless identified as Premium)
 <br/>
 <br/>
 $82,000 (entry-level qualifications) to $90,200 (highly experienced) annually
 <br/>
 <br/>
 Premium Market (Premium markets include Los Angeles, San Diego, San Francisco, New York City, Chicago, &amp; Boston)
 <br/>
 <br/>
 $87,000 (entry-level qualifications) to $95,700 (highly experienced) annually
 <br/>
 <br/>
 The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed.
 <br/>
 <br/>
 ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options
 <br/>
 <br/>
 <ul>
  <li>
   Health and Financial Wellness Programs
  </li>
  <li>
   Employer Assistance Program (EAP)
  </li>
  <li>
   Company Paid and Voluntary Life/AD&amp;D, Short-Term and Long-Term Disability
  </li>
  <li>
   Healthcare and Dependent Care Flexible Spending Accounts
  </li>
  <li>
   401(k) Retirement Plan with Company Match
  </li>
  <li>
   529 Education Savings Program
  </li>
  <li>
   Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks
  </li>
  <li>
   Paid Time Off (PTO) includes: 11 Holidays
  </li>
  <li>
   Exempt Employees are eligible for Unlimited PTO
  </li>
  <li>
   Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day
  </li>
  <li>
   We are committed to providing you with the tools and resources you need to optimize your Health and Wellness.
   <br/>
   <br/>
  </li>
 </ul>
 At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.
</div>


Clinical Research Associate, In-House

Wicked Technologies

<p>Wicked Technologies is building the Wicked Smart Pad (WSP) &mdash; an IoT-enabled smart incontinence monitoring system designed for senior living and memory care communities. Our mission is to improve care quality by enabling faster response times, reducing skin breakdown, and enhancing resident dignity.</p><p>We are preparing to execute a lean, real-world pilot study across ~2 senior living communities (&asymp;50 residents total).</p><p>Engagement Timeline<br/>Study Execution: July &ndash; September 2026<br/>Closeout &amp; Reporting: October &ndash; December 2026</p><p>Role Overview<br/>We are seeking a Clinical Trial Lead to design, operationalize, and execute a funded clinical study.</p><p>You will own the study from protocol finalization &rarr; SOP authorship &rarr; site execution &rarr; data &rarr; final report.</p><p>What&rsquo;s Already in Place<br/>-Draft study design aligned to reimbursement strategy<br/>-Defined high-level endpoints and use case<br/>-Identified target sites and population</p><p>Key Responsibilities<br/>-Protocol Finalization &amp; SOP Development<br/>-Refine and finalize the study protocol<br/>-Own authorship of lean, fit-for-purpose SOPs, including:<br/>-Study execution / site operations<br/>-Data collection &amp; handling<br/>-Protocol deviations &amp; issue handling<br/>-Device usage within study context<br/>-Ensure documentation is credible (audit-defensible) but not overbuilt<br/>-Recommendations for scale + reimbursement pathway</p><p>Ideal Candidate<br/>-Experience leading medical device clinical studies or pilot trials<br/>-Proven ability to write SOPs and operationalize studies from scratch</p><p>Please include:<br/>-Relevant study experience (especially lean or real-world trials)<br/>-Your approach to running a fast, pragmatic clinical study</p><p>Pay: $50.00 - $100.00 per hour</p><p>Work Location: In person</p>

bioMerieux

<div><p>The Clinical Research Scientist (CRS) leads the execution of the clinical studies that make up the company&rsquo;s clinical evidence generation program. In this role, you will execute clinical studies and/or programs worldwide in accordance with strategy, project plans, approved budget and resource allocations following applicable regulatory and standard operating procedures.</p><p>
The Clinical Research Scientist collaborates closely with cross-functional teams, including associate Clinical Research Scientists, Disease State Scientists, Biostatistics &amp; Data Management, Logistics, Medical Writers, Regional Medical Affairs teams and other stakeholders to generate impactful clinical evidence that supports the company&rsquo;s strategy. This role is crucial in maintaining our commitment to scientific excellence and patient-centric approaches within the competitive global healthcare landscape.</p><p></p><p><b><i><br>
This position can be located in either St. Louis, MO OR Salt Lake City, UT.</i></b></p><p><b>
Primary Duties</b></p><p>
Team and Cross Functional Leadership:<br>
a. Leads the study team in the execution of clinical studies to meet the Evidence Generation Plan from study synopsis to data lock and final study report<br>
b. Partner with internal stakeholders to lead the development, review, and finalization of clinical protocols to meet regulatory and scientific objectives<br>
c. Contribute to the development of the study synopsis<br>
d. Partner with key stakeholders to create and manage the study execution team<br>
e. Collaborate closely with cross-functional teams including Regulatory Affairs, Quality Assurance, Biostatistics, Program Management, external vendors, and contract research organizations (CROs) to ensure high-quality study conduct<br>
f. Mentor Associate Clinical Research Scientist(s) and provide guidance on clinical operations processes, study management and other study execution tasks
</p><p><b>Study Planning, Strategy and Reporting:</b><br>
a. Develop and manage study budgets, timelines, enrollment strategies, and resourcing requirements to ensure study milestones are met<br>
b. Develop and manage all required plans including clinical study project plans, study execution plans, risk and risk mitigation plans, monitoring plan, and communication plans<br>
c. Contributes to or leads the development of abstracts/posters of study results in collaboration with study team<br>
d. Develop clinical study reports and/or contribute to the development of scientific publications
</p><p><b>Study Management and Site Management:</b><br>
a. Manage all aspects of clinical trial operations including study start-up, site initiation, patient enrollment, monitoring, and study close-out for bioM&eacute;rieux initiated research studies and collaborative studies<br>
b. Track study progress and provide regular status reports to stakeholders<br>
c. Assure study metrics and budget are input to corporate systems<br>
d. Oversee site selection, feasibility, study startup, site activation, enrollment, and ongoing execution<br>
e. Oversee clinical monitoring and data integrity<br>
f. Update trial management systems, including timelines and budgets<br>
g. Perform on-site and remote site qualification visits, site initiation visits, interim monitoring visits and site close out visits as required<br>
h. Oversee clinical site activities, reference laboratories, CROs, and other external partners to ensure adherence and compliance with protocol timelines, budgets, study milestones and quality standards<br>
i. Manage and coordinate IRB/EC document creations and communications<br>
j. Manage clinical trial agreements for sites<br>
k. Manage study documentation and filing with electronic trial master file (eTMF) platforms
</p><p><b>Regulatory Compliance:</b><br>
a. Follow Corporate (e.g., SOP&rsquo;s) and local/regional regulatory requirements<br>
b. Participate in the review and revision of Clinical Operations Standard Operating Procedures (SOPs) to assist Medical Affairs leadership with continuous process improvement initiatives
</p><p><b>Quality and Compliance:</b><br>
a. Identify and mitigate risks throughout the clinical trial lifecycle<br>
b. Assure a quality plan is in place
</p><p><b>Data Management:</b><br>
a. Oversee and manage electronic data capture (EDC) systems<br>
b. Oversee data collection activities, compliance, and inspection readiness<br>
c. Oversee electronic trial master file (eTMF) platforms to ensure data integrity and regulatory compliance
</p><p><b>Communication:</b><br>
a. Lead internal and external study meetings with relevant stakeholders<br>
d. Organize and drive study meetings and other study activities as assigned<br>
e. Participate in core team meetings to provide clinical insights and contribute to strategic decision-making<br>
f. Outline and communicate safety issues and planned mitigations in collaboration with internal stakeholders
</p><p><b>Vendor management:</b><br>
a. Negotiate contracts and budgets in partnership with the legal team<br>
b. Manage clinical trial agreements with external vendors<br>
c. Manage vendor performance according to contract
</p><p>Perform all work in compliance with company quality procedures and standards.
</p><p>Perform other duties as assigned.
</p><p>Experience</p><ul><li>
Bachelor's Degree required in a scientific, medical, or healthcare discipline</li><li>
2+ years of professional related experience in clinical trial management, preferably in diagnostics or medical device required.</li><li>
Certifications including ACRP-CP or ACRP-PM a plus.
</li><li>Excellent knowledge of clinical trial processes, systems, and tools (e.g., CTMS, EDC, eTMF), with the ability to oversee quality, data integrity, and inspection readiness.
</li><li>Proven leadership and stakeholder-management capabilities, with the ability to influence without authority and build strong relationships across functions and with external partners.
</li><li>Experience negotiating clinical research contracts and budgets
</li><li>Knowledge of Good Clinical Practice ICH/GCP and other applicable regulations, fundamental knowledge of clinical research and monitoring requirements
</li><li>Experience managing all major aspects of strategic planning, organization, implementation, and delivery of clinical studies.
</li><li>Understanding the US and European Medical Testing environments and relevant professional societies and guidelines (e.g. FDA, CE-Mark IVD Directives, CAP, CLIA, WHO)
</li><li>Proven track record writing clinical study plans and study protocols
</li><li>Experience with the study budget oversight, risk mitigation, management of timelines, deliverables, and milestones
</li><li>Experience negotiating clinical research contracts and budgets with Investigators and sites
</li><li>Experience with electronic clinical trial systems and clinical data review
</li></ul><p>Knowledge, Skills, &amp; Abilities</p><ul><li>
Consistently upholds and reflects the core ethical principles and values that bioM&eacute;rieux promotes.</li><li>
Ability to work cross-functionally allowing for better collaboration and communication when working across teams to achieve shared objectives</li><li>
Effective Presentation Skills - including the ability to present technical data</li><li>
Solution oriented in the face of conflict</li><li>
Practicing time management to allocate tasks, balance priorities, and meet deadlines efficiently</li><li>
Managing and measuring work by tracking progress, performance, and goal achievement using metrics and KPIs.</li><li>
Skilled in MS Office tools to include but not limited to Outlook, Teams, Word, and Excel
</li><li><ul><li>Advanced: demonstrates deep knowledge; manages complex tasks and integrates multiple tools independently</li></ul></li><li>
Functionally Required Knowledge, Skills, and Abilities
</li><li><ul><li>Ability to manage budget, timelines and multiple projects simultaneously</li><li>
Ability to learn new products and adjust to changing research directions</li></ul></li></ul><div>
The estimated salary range for this role is between $80,000 and $116,700. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bioMerieux&rsquo;s bonus program. This range may differ from ranges offered for similar positions elsewhere in the country given differences in cost of living. Actual compensation within this range is determined based on the successful candidate&rsquo;s experience and will be presented in writing at the time of the offer.</div><div>
In addition, bioM&eacute;rieux offers a competitive Total Rewards package that may include:</div><ul><li>A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options</li><li>Company-Provided Life and Accidental Death Insurance</li><li>Short and Long-Term Disability Insurance</li><li>Retirement Plan including a generous non-discretionary employer contribution and employer match.</li><li>Adoption Assistance</li><li>Wellness Programs</li><li>Employee Assistance Program</li><li>Commuter Benefits</li><li>Various voluntary benefit offerings</li><li>Discount programs</li><li>Parental leaves</li></ul><div>
</div><div>
#LI-US</div></div>

Clinical Research Scientist

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10000 clinical trial manager jobs Near Me

Clinical Trial Program Manager

Clinical Trial Project Manager

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Clinical Trial Coordinator

Clinical Research Associate, In-House

Clinical Trial Coordinator

Clinical Research Scientist