Associate Director, Clinical Trial Manager
Cambridge, Massachusetts
Development – Clinical Development /
Full-time /
Hybrid
This position will lead a cross-functional clinical development team to ensure the successful planning, execution, and close-out of an upcoming Phase 1/2a clinical study and other studies, as needed. This individual will manage and oversee internal and external study activities, managing and overseeing a CRO and other vendors. The position will be a member of the Clinical Operations group, reporting to the Director, Clinical Operations.
Responsibilities:
- Perform day to day management and oversight of assigned clinical trial to ensure deliverables are met timely and within budget
- Manage trial feasibility process and oversee site feasibility/capability assessments in collaboration with the CRO and cross-functional team
- Develop and maintain study level timelines and budget with internal leadership and CRO
- Work with CRO to provide monthly metrics report to track against timelines (i.e. study dashboard report)
- Responsible for ongoing study communication and escalation of study-related issues as required
- Develop and adhere to vendor oversight plans
- Contribute to or author relevant study documents such as the protocol, informed consent form, investigator brochure, clinical study reports and other documents and plans, as appropriate
- Prepares/oversees the preparation of all applicable documents required for the conduct of the study (Project Plan, Risk Management Plan, Monitoring Plan, Trial Master File (TMF)).
- Ensure the TMF is set up and maintained appropriately throughout the trial, including periodic reviews
- Oversight and review of data management outputs
- Responsible for protocol deviation review and listing
- Participate in and provide feedback during RFI, RFP and bid defense process for new studies
- Participate and review quality plans and audit reports for the study and provide oversight of CAPA resolution with the CRO, vendors and sites, as needed
- Oversee any subcontracted vendors through CRO
- Review and track monitoring report issues, GCP compliance concerns and monitor performance; oversight of timely issue resolution at sites; Perform and/or coordinate sponsor oversight visits at the clinical sites to ensure quality of monitoring and sites adherence to GCP
- Oversight of the eTMF for the trial and will ensure an audit/inspection ready Participate and review SOPs for clinical operations and other functional areas as needed
- Ensure all study activities are completed in accordance with country specific ICH GCP, health authority regulations and company SOPs
- Support during relevant inspections (e.g., FDA)
- Assist CRO with planning of Investigator Meetings and associated travel
- Facilitate review of clinical trial agreements
- Identifies potential risks form study and works with the team to resolve any issues
- Participates in UATs, e.g., EDC, IRT
- Mentoring assigned Clinical Trial Coordinator
Minimum Requirements:
- Bachelor’s degree in the Life Sciences or equivalent is required
- 8 years of experience in clinical operations is required
- Ability to build strong relationships with the sites and CRO including providing feedback as well as oversight
- Passion for working in a small company environment – including being self-motivated and proactive
- Ability to think of big picture as well as being adept at detail-orientation
- Up to 20% travel may be required
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