Clinical Trial Manager (Remote)
Work In Biotech
- Boston, MA
- Permanent
- Full-time
- Works closely with the Associate Director and will be responsible for oversight, planning, and execution of assigned clinical studies, timelines, and key deliverables.
- Manage all operational aspects of assigned clinical trial(s)Support the selection of vendors/CROs and provide effective ongoing management to vendors/CROs to ensure compliance and execution of deliverables within the approved budget, study timeline, and study protocol.
- Independently manages assigned clinical studies.
- Monitor and track clinical trial progress and provide status updates to stakeholders and at project team meetings to senior management as needed.
- Oversee all aspects of data cleaning and facilitate data locks, including oversight of clinical sites, CRO, vendors, and collaboration with data management/statistics teams.
- Proactively identify potential issues/risks and recommend/implement solutions.
- Coordinates and/or participates in the development of clinical study documents including ICF, monitoring plans, recruitment plans, and other program/study-related documents.
- Oversees and works directly with CROs, vendors, and all other partners. Establishes relationships with investigators, study coordinators, site personnel, and other external key stakeholders.
- Accountable for developing and managing study budgets and financial reporting, including month-end and quarterly reporting, financial reconciliation, accruals, and re‐forecasting, with Clinical, Finance, and Project Management
- Works with the Patient Recruitment/ Advocacy department and is responsible for the oversight of the recruitment strategy, enrollment projections, and meeting established targets.
- Presents at clinical team meetings and other forums on study progress.
- May travel to site visits, co-monitoring visits, Investigator Meetings, and conferences as applicable.
- Thorough understanding of FDA, ICH, and GCP guidelines
- Proven track record showing clear proficiency in clinical trial management skills
- Proven complex problem-solving skills collaboratively and independently
- Solid vendor management experience, e.g., CRO, laboratory, and /or clinical supply logistics
- Broad understanding of clinical operations related to the pharmaceutical drug development process
- Ability to effectively interface with personnel at clinical sites
- Ability to write and edit technical documents, such as protocols, protocol amendments, informed consent, and other trial-related documents
- Excellent interpersonal, verbal, and written communication skills
- Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities
- BA, BS in biological science, or degrees in nursing, pharmacy, medical technology, or other allied healthcare
- Minimum of 5 years of clinical trial management experience, at least 3 of which are as a Clinical Trial Manager for clinical development studies at a pharmaceutical/biotech organization or a combination of CRO and pharmaceutical/biotech
- Experience with Phase I - III clinical trials
- Proficiency with computer programs such as Google Suite & Microsoft Office