Convergent Therapeutics, Inc.
Clinical Trial Management Associate (no agencies please)
Convergent Therapeutics, Inc., Boston, Massachusetts, us, 02298
Clinical Trial Management Associate (no agencies please)
Convergent Therapeutics is seeking a highly organized and proactive Clinical Trial Management Associate (CTMA) to support the successful execution of our clinical trials. In this key role, you will partner closely with the Clinical Trial Manager (CTM) and Director, Clinical Operations to manage critical components of study delivery—ensuring timelines, quality standards, and budget expectations are met. You will drive meeting coordination, site and vendor support, documentation management, and quality oversight across assigned studies. The successful candidate will support Convergent’s clinical trial(s), ensuring the safety of patients, good oversight of all vendors and high quality of the clinical trial data in adherence with all applicable regulations.
Responsibilities
Independently perform tasks related to the day-to-day clinical trial management with the implementation and conduct of clinical trials, enrollment, site management and monitoring oversight, data quality and study reporting.
Support Clinical Trial Manager (CTM) in the drafting/review of informed consents, case report forms, or clinical study reports.
Collect, track and conduct initial review for completeness of site regulatory documents site activation and/or TMF filing, with CTM oversight.
Support and/or contribute to the creation and maintenance of study materials, including but not limited to site and CRA training materials, regulatory document templates, study binders, study plans/manuals, site tools, study communications and presentations.
Manage third‑party vendors with CTM oversight to ensure timely delivery of services/materials and coordinate activities, including vendor provided meeting minutes, study updates and trackers.
Maintain trackers following the progress of assigned clinical trials, such as study subject tracking, essential document tracking.
Track trial investigational product, clinical lab samples and lab data, sample shipments and reconcile with sites, as needed.
Support CTM in the review, tracking and follow‑up of monitoring visit reports and unresolved issues.
Collect and collate site feasibility data as needed.
Facilitate execution of new CDAs and site contracts through the established legal approval process (CTAs, MSAs, work/task orders).
Perform first pass review of site and some vendor invoices including tracking and generation of monthly/quarterly accruals.
Communicate directly with sites, Contract Research Organizations (CROs) and CRAs/monitors to obtain updated information, essential documents, etc. to assist with driving start‑up, study conduct, and/or close‑out activities.
Responsible for the scheduling, agendas and minutes of internal clinical team meetings and other trial‑specific meetings.
Receive and review regulatory documents from sites (directly or through CRO) for accuracy and compliance with applicable SOPs and regulatory guidelines.
Ensure timely updates of required trial registry websites, with CTM oversight.
Support the team in the development, review and implementation of departmental SOPs and processes.
Organize, maintain and participate in the audit and close‑out of the Trial Master File (TMF/eTMF).
Support study system specifications (e.g. EDC, IRT, ePRO) and user acceptance testing (UAT) processes, as appropriate.
Participate in Investigator Meetings, including presenting materials when appropriate.
Perform other duties as assigned based on Clinical Operations expertise.
Requirements
Bachelor’s degree in health sciences or equivalent.
3+ years of experience in working on phase I‑IV global clinical studies within a biopharmaceutical/biotech, CRO, or academic environment.
Oncology experience required. Prostate cancer experience highly preferred.
Experience and understanding of global clinical trial operations; preference in the oncology and/or cell therapy space.
Current knowledge of Good Clinical Practices, ICH Guidelines, and FDA regulations and the application of the conduct to clinical studies.
Ability to interpret and communicate protocol requirements.
Demonstrated experience managing components of clinical trials independently.
Advanced proficiency with clinical trial software platforms, vendor systems, and related tools.
Understanding of data‑technology interdependencies, vendor metrics, and operational nuances across vendor types.
Ability to interface with medical personnel at clinical site(s) and support multi‑disciplinary teams both internally and externally.
Must be proficient in MS Office Suite (Word, Excel, PowerPoint) and project management programs.
Excellent communication skills. Ability to communicate in an open, clear, timely and consistent manner.
Ability to contribute as a team member in a dynamic, fast‑paced biotech environment.
The candidate must reside in the Greater Boston area.
10% to 20% travel required.
Equal Opportunity Employer We are committed to recruiting, developing, and retaining the most talented people from a diverse candidate pool. All aspects of employment, including the decision to hire or promote, will be based on aptitude, performance, and business need. We do not discriminate on the basis of race, color, religion, sex, national origin, age, physical or mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, or any other legally protected status. We will make reasonable accommodation for qualified individuals in accordance with applicable law.
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Responsibilities
Independently perform tasks related to the day-to-day clinical trial management with the implementation and conduct of clinical trials, enrollment, site management and monitoring oversight, data quality and study reporting.
Support Clinical Trial Manager (CTM) in the drafting/review of informed consents, case report forms, or clinical study reports.
Collect, track and conduct initial review for completeness of site regulatory documents site activation and/or TMF filing, with CTM oversight.
Support and/or contribute to the creation and maintenance of study materials, including but not limited to site and CRA training materials, regulatory document templates, study binders, study plans/manuals, site tools, study communications and presentations.
Manage third‑party vendors with CTM oversight to ensure timely delivery of services/materials and coordinate activities, including vendor provided meeting minutes, study updates and trackers.
Maintain trackers following the progress of assigned clinical trials, such as study subject tracking, essential document tracking.
Track trial investigational product, clinical lab samples and lab data, sample shipments and reconcile with sites, as needed.
Support CTM in the review, tracking and follow‑up of monitoring visit reports and unresolved issues.
Collect and collate site feasibility data as needed.
Facilitate execution of new CDAs and site contracts through the established legal approval process (CTAs, MSAs, work/task orders).
Perform first pass review of site and some vendor invoices including tracking and generation of monthly/quarterly accruals.
Communicate directly with sites, Contract Research Organizations (CROs) and CRAs/monitors to obtain updated information, essential documents, etc. to assist with driving start‑up, study conduct, and/or close‑out activities.
Responsible for the scheduling, agendas and minutes of internal clinical team meetings and other trial‑specific meetings.
Receive and review regulatory documents from sites (directly or through CRO) for accuracy and compliance with applicable SOPs and regulatory guidelines.
Ensure timely updates of required trial registry websites, with CTM oversight.
Support the team in the development, review and implementation of departmental SOPs and processes.
Organize, maintain and participate in the audit and close‑out of the Trial Master File (TMF/eTMF).
Support study system specifications (e.g. EDC, IRT, ePRO) and user acceptance testing (UAT) processes, as appropriate.
Participate in Investigator Meetings, including presenting materials when appropriate.
Perform other duties as assigned based on Clinical Operations expertise.
Requirements
Bachelor’s degree in health sciences or equivalent.
3+ years of experience in working on phase I‑IV global clinical studies within a biopharmaceutical/biotech, CRO, or academic environment.
Oncology experience required. Prostate cancer experience highly preferred.
Experience and understanding of global clinical trial operations; preference in the oncology and/or cell therapy space.
Current knowledge of Good Clinical Practices, ICH Guidelines, and FDA regulations and the application of the conduct to clinical studies.
Ability to interpret and communicate protocol requirements.
Demonstrated experience managing components of clinical trials independently.
Advanced proficiency with clinical trial software platforms, vendor systems, and related tools.
Understanding of data‑technology interdependencies, vendor metrics, and operational nuances across vendor types.
Ability to interface with medical personnel at clinical site(s) and support multi‑disciplinary teams both internally and externally.
Must be proficient in MS Office Suite (Word, Excel, PowerPoint) and project management programs.
Excellent communication skills. Ability to communicate in an open, clear, timely and consistent manner.
Ability to contribute as a team member in a dynamic, fast‑paced biotech environment.
The candidate must reside in the Greater Boston area.
10% to 20% travel required.
Equal Opportunity Employer We are committed to recruiting, developing, and retaining the most talented people from a diverse candidate pool. All aspects of employment, including the decision to hire or promote, will be based on aptitude, performance, and business need. We do not discriminate on the basis of race, color, religion, sex, national origin, age, physical or mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, or any other legally protected status. We will make reasonable accommodation for qualified individuals in accordance with applicable law.
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