Senior Clinical Trial Manager - Cambridge
The Senior Clinical Trial Manager will be responsible for the planning and execution of a registrational protocol in a highly visible program. The Sr. CTM will assume many critical activities including the management of internal and external stakeholders, ownership of the clinical trial strategy for execution, serving as a key participant in regulatory discussions and leading a high performing study team towards shared objectives.
- Manages all clinical aspects of study including:
- Responsible for selection, qualification, and management of vendors to support clinical trial execution
- Develops and manages comprehensive study timelines and metrics and ensures completion of study deliverables
- Proactively identifies and resolves clinical project issues
- Provides study-specific training and leadership to clinical research staff, CRO, CRAs, sites and other contract personnel;
- Plans, executes, and leads study-specific meetings (e.g., internal core team meetings, investigator meetings, Advisory Committee)
- Participates in site monitoring visits as appropriate
- Provides input for the design of the Informed Consent Form(s), CRFs, monitoring conventions, edit checks, etc
- Reviews monitoring reports to ensure quality and resolution of site-related issues
- Ensures tracking and review of protocol deviations and assesses impact on study data
- Uses operational and therapeutic expertise to optimize trial design and execution.
- Typically works with the Director to design clinical trial protocols consistent with the clinical development plan and develop an ongoing data review plan to ensure appropriate patient recruitment
- Develops relationships with investigators and site staff; critical to be comfortable engaging KOLs in scientific discussion
Qualifications (Education, Experience, Knowledge and Skills):
- BS/BA in life sciences preferred
- A minimum of 3 years of direct experience in clinical trial execution
- Experience managing clinical trials both fully outsourced as well as managed directly
- Prior experience developing and managing clinical trial budgets
- Experience managing external contract research relationships.
If you or a Senior Clinical Trial 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.