clinical trial data manager

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)

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 Brigham and Women's Hospital, Inc.

<div>Site: The Brigham and Women's Hospital, Inc.<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><p></p><p><b><br>
Job Summary</b></p>
Summary<br>
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). Does this position require Patient Care? No<br>
Essential Functions Overall responsibility for operational and budgetary management of multi-site clinical trials. -Assists PI and Director, Clinical Trial Operations in development of protocol, informed consent, CRF&rsquo;s and operations manuals.
<br>
<ul><li>Responsible for submitting all deliverable reports for a trial to sponsor and appropriate regulatory agencies.
</li><li>Oversees submission of protocol to IRB and ensures timely responses to IRB comments.
</li><li>Supervises research assistants and coordinators assigned to study.
</li><li>Coordinate and respond to audits by study sponsors.</li></ul><p></p><div><div><div><div><div><div><div><p><b><br>
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>
Directly related experience in clinical research 3-5 years required and Prior Supervisory Experience 2-3 years preferred<br>
<br>
Knowledge, Skills and Abilities<br>
<ul><li>Capability of prioritizing multiple competing tasks and seek supervisory or administrative assistance when appropriate.</li><li>Experience with Data Management systems and software Packages.</li><li>Strong interpersonal skills and the ability to supervise others.</li><li>Ability to work independently and display initiative to introduce innovations to research study.</li><li>Ability to identify problems and develop solutions.</li><li>Ability to prioritize tasks and set deadlines.</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>
221 Longwood Avenue<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>
2200 The Brigham and Women's Hospital, Inc. 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 Trials Project Manager

AskBio Inc.

<div>
 AskBio Inc., a wholly owned and independently operated subsidiary of Bayer AG, is a fully integrated gene therapy company dedicated to developing life-saving medicines and changing lives. The company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular, and metabolic disease indications with a clinical-stage pipeline that includes investigational therapeutics for congestive heart failure, limb-girdle muscular dystrophy, multiple system atrophy, Parkinson&rsquo;s disease, and Pompe disease. AskBio&rsquo;s gene therapy platform includes Pro10&trade;, an industry-leading proprietary cell line manufacturing process, and an extensive array of capsids and promoters. With global headquarters in Research Triangle Park, North Carolina, and European headquarters in Edinburgh, Scotland, the company has generated hundreds of proprietary capsids and promoters, several of which have entered pre-clinical and clinical testing.
 <br/>
 <br/>
 <strong>
  Our vision:
 </strong>
 Pioneering science to create transformative molecular medicines.
 <br/>
 <br/>
 <strong>
  Our mission:
 </strong>
 Lead innovative science and drive clinical outcomes to transform people's lives.
 <br/>
 <br/>
 <strong>
  Our Principles
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Advance innovative science by pushing boundaries.
  </li>
  <li>
   Bring transformative therapeutics to patients in need.
  </li>
  <li>
   Provide an environment for employees to reach their fullest potential.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Our Values
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need.
  </li>
  <li>
   Cultivate Collaboration. Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view.
  </li>
  <li>
   Embrace Responsibility. We are humbled by the enormity of our mission. We hold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers.
  </li>
  <li>
   Raise the Bar. Continuously drive improvements and efficiencies. Seek and provide constructive feedback. Have a bias for learning and action.
  </li>
  <li>
   Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what&rsquo;s right in every situation. Make clear commitments and follow through.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Position Summary
  <br/>
  <br/>
 </strong>
 The Clinical Trial Management Intern will support our Clinical Trial Management team in the overall foundational organization of our clinical trials, including planning, execution, and closeout with the goal of increasing efficiency and consistency within the function.
 <br/>
 <br/>
 The intern will report to a member of the Clinical Trial Management team and will be based on-site in RTP, NC.
 <br/>
 <br/>
 <strong>
  Job Responsibilities
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Schedule activities and meetings, including compilation of materials and overseeing presentations
  </li>
  <li>
   Responsible for taking and distributing meeting minutes and tracking action items for both internal and external meetings as well as reviewing for accuracy
  </li>
  <li>
   Participate in clinical trial management study-related activities on an as needed basis
  </li>
  <li>
   Assist the CTMs in tracking various components of the clinical studies
  </li>
  <li>
   Take meeting minutes and track actions as applicable for clinical trial activities
  </li>
  <li>
   Review and submit files within the Trial Master File, for Clinical Operations-related documentation
  </li>
  <li>
   Track review of and file monitoring reports and associated documents
  </li>
  <li>
   Collaborate with cross-functional team members during normal business operations
  </li>
  <li>
   Creating, distributing, and updating trackers for metric reporting
  </li>
  <li>
   Support departmental initiatives and process improvements
  </li>
  <li>
   Other duties and responsibilities as required
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Minimum Requirements
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Must be pursuing a Bachelor&rsquo;s degree in a scientific, healthcare, project management or related field
  </li>
  <li>
   Must be at least a Junior in university at the time of your application
  </li>
  <li>
   Proficient computer skills (Microsoft Suite, SmartSheet) and ability to learn new technologies quickly
  </li>
  <li>
   Excellent verbal and written communication skills
  </li>
  <li>
   Proactive and solution-driven mindset
  </li>
  <li>
   Strong sense of accountability and ability to prioritize multiple tasks
  </li>
  <li>
   Excellent organizational skills and attention to detail
  </li>
  <li>
   Flexible and willing to support a variety of tasks for the Clinical Trial Management team
  </li>
  <li>
   Available to work full-time during the summer months (May-August) at an AskBio office
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Preferred Education, Experience And Skills
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Students enrolled in a Master&rsquo;s program in a scientific, healthcare or project management related field are encouraged to apply
  </li>
  <li>
   Prior internship, work, or volunteer/extracurricular experience
   <br/>
   <br/>
  </li>
 </ul>
 <em>
  AskBio Inc. (AskBio) is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or any other protected status prohibited under Federal, State or local laws. All employment decisions are based on valid job&hyphen;related requirements. If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening by calling us at (919) 561-6210 or sending us an email at careers@askbio.com.
  <br/>
  <br/>
 </em>
 <em>
  Agencies: Please do not contact any employee at AskBio about this requisition. Any resume submitted by a recruitment agency to any employee at AskBio, through any medium, will be deemed the sole property of AskBio
 </em>
 unless
 <em>
  the agency was engaged by AskBio Talent Acquisition team to recruit for that position. All agencies must have a prior executed service agreement with AskBio prior to any search engagement. If a candidate who was submitted outside of the AskBio agency process is hired by AskBio, no fee or payment of any kind will be paid to the agency.
 </em>
</div>


Intern-Clinical Trial Management

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>
<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

TRIO - Translational Research in Oncology

<div><p>Translational Research in Oncology (TRIO) is a global academic clinical research organization dedicated to advancing translational cancer research in the clinical trial setting. Our passionate team is committed to providing cancer treatments of the future to the world of today.<br>
<br>
TRIO is looking for a <b>Clinical Research Physician</b> to join our<b> Medical Monitoring Unit team</b>. Reporting to the <b>Medical Monitoring Unit Manager</b>, this will be a home-based, full-time position in the USA.</p><p><b>
Main Responsibilities:</b></p><ul><li>
Act as Medical Monitor, performing comprehensive medical monitoring activities.</li><li>
Respond to medical inquiries from investigational sites and trial teams.</li><li>
Review patient eligibility and protocol deviations.</li><li>
Oversee patient safety by reviewing medical data at patient and trial levels.</li><li>
Review Serious Adverse Events (SAEs), including coding, causality and expectedness assessments, and drafting company comments.</li><li>
Prepares scientific slides, attends and/or presents protocol information at Investigator Meetings, Scientific Committee meetings, Safety Review Committee meetings, SIVs, etc.</li><li>
Serve as the primary clinical point of contact for scientific questions from internal and external stakeholders (e.g., IRBs, sites, sponsor medical teams, trial teams).</li><li>
Collaborates with the Medical Writing and Training Unit to write and/or review trial-specific medical documents (e.g., protocols, DSURs, CSRs).</li><li>
Conducting medical training on selected trial-specific or non-trial-specific topics.</li></ul><p><b>
Qualifications:</b></p><div><ul><li>
Medical Doctor degree required</li><li>
Excellent knowledge and understanding of oncology and oncology clinical trials</li><li>
At least 1 year of experience in medical monitoring in oncology trials</li><li>
Current knowledge of ICH GCP guidelines</li><li>
Advanced proficiency in MS Office in Word, Excel, and PowerPoint</li><li>
Strong teamwork abilities and communication skills</li><li>
Excellent level of English is required</li><li>
Spanish language knowledge will be valued</li><li>
Must be legally authorized to work in the country</li></ul></div><p><b>
What TRIO Can Offer You:
</b></p><ul><li>Competitive Salary</li><li>
3 weeks of vacation plus paid Christmas Closure</li><li>
2 weeks paid personal/sick time</li><li>
100% health benefits for you and your family paid by TRIO</li><li>
Flexible working hours</li><li>
Monthly internet allowance</li><li>
401K Program 5% Salary Contribution</li><li>
Home office allowance</li></ul><p>
Pay Range: $110,000 - $150,000. Salary to be influenced (or determined) by the education, experience, location, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data.</p><p></p><p><br>
Prior to applying please review TRIO's Applicant Information Notice</p>
<p>To support efficiency, TRIO may use limited AI tools during the candidate review process. All hiring decisions are made by people, not AI.<br>
<br>
To ensure fairness and an accurate understanding of your skills, we ask that candidates refrain from using AI tools or AI‑generated responses during interviews or assessments. We want the opportunity to get to know you and your experience.</p>
<p><b>Teamwork &middot; Passion &middot; Integrity &middot; Innovation
</b></p><p></p><p>PcKtvbLyFN</p></div>

Clinical Research Physician

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

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