Clinical Trial Manager
Obsidian Therapeutics
full-time
Posted on:
Location Type: Office
Location: Cambridge • Massachusetts • 🇺🇸 United States
Visit company websiteSalary
💰 $114,500 - $140,000 per year
Job Level
Mid-LevelSenior
Tech Stack
Google Cloud Platform
About the role
- Support all clinical aspects of clinical trial operations from site selection and qualification, through study initiation to close out ensuring study deliverables are met on time and all relevant metrics are tracked and reported.
- Contribute to the development of study execution plans, partner with internal and external teams (Regulatory Affairs, Program Management, CMC, CRO, investigators/site staff, specialty labs, etc.), identify and mitigate risk throughout the study lifecycle.
- Assist in development of study budget, review and approve clinical invoices, and oversee expenses to ensure all fall within approved budget.
- Oversee study start up and site initiation activities and ensure clinical research staff including CRO, CRAs, sites and other contract personnel receive study-specific training and leadership.
- Contribute to writing clinical protocols, study related documentation (ICF template, CRFs, CRF Completion Guidelines Monitoring Plan, Laboratory Manual, TMF plan, Pharmacy Manual, etc.) and regulatory documents such as INDs.
- Prepare and review site study documents (e.g. site-specific informed consent, study tools/worksheets, investigator contracts, and site payments).
- Ensure the Trial Master File (TMF) documentation is complete and up to date.
- Oversee laboratory sample management and ensure clinical supplies are available for sites.
- Participate in quality assurance activities (review of protocol deviations, site specific CGP issues, review of monitoring reports, etc.) and ensure audit-ready condition of clinical trial documentation including central clinical files/Trial Master Files.
- Oversee clinical monitoring activities ensuring compliance with ICH/GCP and applicable regulations.
- Assist in developing and managing an ongoing data review plan to ensure detection of data trends and to ensure study objectives are met.
- Prepare and present project briefings as required. Plan and facilitate study-specific meetings with CRO or other vendors (e.g., Study Management Meetings, investigator meetings, etc.).
- Participate in selection and management of external vendors, develop vendor specifications, and review vendor reports, budgets, and metrics.
Requirements
- BS/BA/RN Degree with 8+ years of experience in a life science or a health-related field is preferred.
- Minimum of 5+ years working on phase I-IV clinical studies, ideally at a sponsor, CRO or clinical study site in management of oncology, rare disease, or cell/gene therapy trials
- Strong understanding of regulatory (e.g., ICH-GCP, FDA and EU regulations) and Compliance requirements
- Biotech/biopharma sponsor experience, including oversight of CROs in multi-site studies.
- Strong understanding of clinical study data review and data management processes, including Data Monitoring, protocol deviations, and overall data integrity of studies.
- Initiative to recognize gaps and opportunities for improvement and develop solutions.
- An ability to manage multiple responsibilities in parallel in a dynamic and fast paced environment with high standards.
- Exceptional attention to detail, organization, and record-keeping.
- Excellent oral and written communication skills
- Analytical thinking; proactive and intuitive about clinical trial issues/risks
- Exceptional risk mitigation and problem-solving skills
- Proficient in MS Office Suite
- Ability to travel up to 20%.
Benefits
- comprehensive medical, dental, and vision coverage
- company contributions to health savings and retirement accounts
- ample paid time off
- access to wellness programs
- rich career growth opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical trial operationsstudy execution plansclinical protocolsdata reviewdata managementrisk mitigationclinical monitoringbudget managementquality assuranceregulatory compliance
Soft skills
attention to detailorganizationcommunicationanalytical thinkingproblem-solvinginitiativemulti-taskingleadershipcollaborationproactive
Certifications
BS/BA/RN Degree