Sr. Clinical Project Manager

Senior Clinical Project Manager - Cambridge (2/3 days of remote flexibility)

Job Summary:

The Sr. Clinical Project Manager provides management and leadership to plan, prepare and execute multiple high-quality clinical projects and /or programs.The Sr. CPM 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.

Major Responsibilities:

  • Responsible for selection, qualification, and management of vendors to support clinical trial execution
  • Proactively develops outsourcing specifications for vendor requests for proposals and leads study team in vendor identification, selection and management
  • Responsible for providing oversight in the development of operational plans, prioritizes tasks within the plans to achieve project goals, while ensuring quality and compliance to Protocol, SOPs, Federal and international regulations and GCP
  • Develops and manages comprehensive study timelines and metrics and ensures completion of study deliverables
  • 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):

  • A minimum of 6 managing CROs
  • Expert knowledge of current GCP regulations and other applicable regulations
  • Strong study management track record demonstrating expertise in clinical project management skills
  • Experience managing clinical trials both fully outsourced as well as managed directly
  • Experience managing external contract research relationships.

If you or a Clinical Program 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) to discuss this role.

Thank you!

Sthree US is acting as an Employment Business in relation to this vacancy.