Senior Clinical Project Manager - Cambridge, MA
A pharmaceutical company located in Cambridge is looking for a Senior Clinical Project Manager, who can step in immediately. A strong candidate will be someone who can roll-up their sleeves and get things done. This position will be primarily in-house, but can be flexible with 1 or 2 days remote flexibility.
- Proactively monitor study and provide at least monthly updates to management team, vendors and contract staff concerning status and progress of the trial. (milestones, timelines, budget, spend, site performance
- Coordination and execution of operational aspects of the clinical trial(s) including identifying and managing vendors, oversee clinical supplies across the study, work with manufacturing and regulatory to manage investigational product supplies.
- Facilitate confidentiality agreements, study agreements and budgets with sites and external vendors.
- Responsible for writing or reviewing, and/or approving clinical project deliverables such as trial documents, investigational product labeling/kitting, pharmacy manual/dosing instructions, Model informed consent, review of IRB submission documents, review regulatory documents for site activation, review all draft study plans and assist with developing study tools, CRFs, DMP, edit checks, safety plan, DMC charter, close-out plans, and CSRs.
- Perform oversight of the trial to ensure accurate reporting of safety and all adverse events/SAEs are properly tracked and reported.
- Ensure clinical trial team and sites are properly trained and in compliance with company and/or CRO SOPs, CFR/EMA regulations, ICH GCP guidance, E6R2 and study protocol.
- Identify gaps in company SOPs and develop internal SOPs as needed.
- Prepare and present study material at client meetings and communicates outcomes to project team at review meetings
- 4+ years of clinical Project Management experience
- 6+ yrs in biotech or biopharma industry, small/start-up environment preferred.
- MUST have previous experience working within oncology clinical trials
- Experience managing clinical trials both fully outsourced as well as managed directly
- Demonstrated proficiency with ICH/GCP guidelines
- Must have strong leadership and decision making abilities
If you or a Senior Clinical Project Manager you know feel this could be an opportunity you would like to explore please send your most up to date resume to myself at Sara.Shields (AT SIGN) Realstaffing.com to discuss this role.
Sthree US is acting as an Employment Business in relation to this vacancy.