6 mo Contract SR CTM-EU Based Site Start Up expert-ET based
Email Template: We are working with a clinical stage neurodegenerative/rare disease sponsor located in San Francisco and searching for an east-coast based, full time, contract Senior level Clinical Trial Manager with experience managing Late Phase, Oncology/Hematology studies with study start up/site activation expertise.
Reporting to the Head of Clinical Ops, you will work with another Senior CTM based in London managing the CRO and starting up/ activating 120 mostly EU-based sites for a Phase III hematology/oncology study in study start up.
Due to the logistics, you can expect early morning meetings with the EU based team, as well as afternoon meetings with the west coast based US team. Therefore, the ability to break in the middle of day will be required in this 40 hour per week contract.
Details and requirements:
-6 month contract to start, 40 hours max/week, w2
-senior level CTM, experience as lead
-late phase hematology/oncology study experience
-experience managing CROs
-Study start up to closeout experience
- start up and site activation expertise
-experience working in a small clinical team environment
If you would like to discuss or may know someone who might be interested, please let me know.
Emerging San Francisco, CA Biopharma - late-stage clinical company, rare disease, neurodegenerative disease pipeline
The Director, Clinical Trial Management will lead the execution of a clinical program or multiple clinical studies, ensuring they are conducted on time, within budget, and of appropriate quality. This individual will have line management responsibilities.
- Maintains accountability for the successful delivery of clinical program or multiple clinical studies from study planning to close-out
- Manages program / study finances. Leads negotiation of vendor contracts, ensuring clarity in contracts and budgets, and oversees vendor performance to contract and agreed budget.
- Oversees or develops integrated study timelines, ensuring close coordination between the study team and external parties
- Ensures clinical trials are conducted in compliance with Good Clinical Practice, local regulations, study protocols, and SOPs
- Ensures that risks to timelines, budgets, or quality are identified proactively, communicated effectively, and mitigated appropriately.
- Manages Clinical Trial Leads to deliver on operational aspects of clinical trials, including site and vendor selection and oversight, study project management, and Trial Master File management
- Oversees the development of fit-for-purpose operational plans (e.g., Monitoring Plan, TMF Plan) and leads team to conduct trial activities in accordance with agreed plans
- Maintains strong relationships with CROs, vendors, and investigative sites
- Works in partnership with key internal functions including, but not limited to Finance, Legal, Regulatory, Biometrics, Clinical Development, and Medical Affairs
- Participates in SOP / process development and other department initiatives, as needed
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