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Associate Director, Clinical Trial Manager
Cambridge, MA
Job Description
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
- 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
#LI-AL1
Equal Opportunity Workplace: At BlueRock, we welcome and support differences and diversity and we are proud to be an equal opportunity workplace. Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs.
Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
8+ years
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