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Clinical Operations Manager (REMOTE)

Cambridge, MA 02138

Posted: 01/26/2023 Employment Type: Contract Job Category: Clinical Development and Operations Job Number: 539968 Is job remote?: Yes Country: United States

Job Description

  • Accountable for planning and operational strategy and execution for oncology and cell therapy stud(ies)
  • Provides subject matter expertise and operational input into protocol synopsis, final protocol and other study related documents
  • Challenges study team to ensure operational feasibility, inclusive of patient and site burden
  • Validates budget and ensures impacts are adequately addressed
  • Participates in country and site feasibility/selection process, with a focus on providing country insights, corporate alignment and therapeutic expertise to ensure alignment between study execution plan and program strategy
  • Challenges study team to ensure timelines meet the needs of the clinical development plan
  • Ensure new team members and vendors are appropriately onboarded
  • During Early Engagement with Strategic Partner(s) and/or other CROs, lead the development of the Operational Strategy in preparation for Operational Strategy Review; focus on ensuring accurate assumptions are applied and robust risk management plans are in place
  • Provide oversight/support/guidance to Strategic partners/CRO to ensure study issues are addressed and resolved rapidly
  • Responsible for study budget planning and management and accountable for external spend related to study execution.
  • Works closely with the Clinical Operations Leader, Global Program Management, and Finance to ensure on a regular basis that budgets, enrollment, and gating are accurate; Communicates study status, cost and issues to Clinical Operations Program Leader; serve as escalation point for third party vendors managed by Strategic Partner and/or other CROs
  • Oversee Strategic Partners/CRO/vendor selection, budget and contract negotiation, and proper supervision of performance for all activities assigned to a Strategic Partner/CRO/vendor, including escalation of issues to governance committees when warranted
  • Review and approval of key monitoring documents/plans, periodic review of outputs, decisions and actions related to monitoring
  • Review and endorsement of relevant study plans, as applicable
  • Study team meeting management and attendance when necessary; regular review of meeting agendas and minutes
  • Review of outcomes/actions related to protocol deviations review; primary purpose of review is to support the identification of trends across sites and/or the study
  • Documented review and monitoring of issues, risks and decisions at the study level and implementation of appropriate mitigation strategies In partnership with data management, review and pressure test all database timelines and plans; review and clean data; ensure strong linkage between the strategy (i.e., filing/registration, data generation, etc.) with the tactical plan for database lock and CSR
  • Ensure studies are inspection ready at all times; may be involved in regulatory inspections by preparing for and/or attending the inspections
  • Represent the Clinical Operations Manager role in functional initiatives or working groups
  • May assist the program Clinical Program Leader in his/her role, as required

Experience must include either early phase clinical studies or Phase 2 and 3 studies and global/international studies or programs. Oncology experience required.

Pay Range: 85-110/hr
Salary will be commensurate with experience
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