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Senior Clinical Trial Manager

  • Location: South San Francisco

Posted 10 days ago

  • Contact: Stefanni LaJeunesse
  • Contact Email:
  • Contact Phone: 310-773-0258
  • Expiry Date: 26 May 2021

Responsibilities for Senior Clinical Trial Manager:

·       Serve as primary point of contact and study lead for CRO management

·       Develop and review key study documents including protocols, ICFs, CRFs, Clinical Study Reports (CSR), NDA submission, and lead development of internal and external study documents/plans including, but not limited to, clinical monitoring and management, Team Charter, TMF management, protocol deviation, Screening/Enrollment closure, pharmacy manual, etc.

·       Fiscal and contracts management: oversee and manage overall study budget and contracts, forecast financials in partnership with finance, reconcile invoices against accruals, ensure accuracy of all CSP work order and change order updates

·       People management: manage and support development of direct and indirect reports by mentoring and delegating responsibilities to junior team members, while overseeing and supporting development plans

·       Partner with Clinical Business Outsourcing (CBO) on CRO/CSP selection process for outsourced activities including RFP development and review, bid defense meetings, CSP performance and issue resolution

·       Lead and serve as subject matter expert (SME) on various company working groups and participate in the development, review and implementation of departmental SOPs and processes

Requirements for Senior Clinical Trial Manager:

Education/Background Requirements:

·       Advanced degree preferred or Bachelor's in a biological science-based subject.

·       At least 8-10 years of clinical trial experience with 2-4 years of direct trial management experience

·       Prior experience as a study coordinator or CRA preferred

·       Experience working within a small biotech company preferred

Position Requirements:

·       Advanced knowledge of clinical research operations, including interpretation and implementation of FDA and other regulatory agency requirements and ICH/GCP guidelines

·       Experience in setup, execution and operational management of domestic and international Phase 1, 2, and 3 clinical trials

·       Able to participate in and lead departmental or interdepartmental strategic initiatives under limited supervision

·       Able to examine functional issues from a broader organizational perspective

·       Forward thinking that effectively translates to a clear sense of direction for teams is essential

·       Strong stakeholder management, influencing and negotiation skills

·       Able to lead cross functional teams with strategic agility

·       Direct line management experience in a leadership or team management position

·       Strong project management skills with ability to manage multiple projects, complex timelines and shift priorities quickly while working under tight deadlines in a team environment

·       Inspection readiness experience highly desired

·       Travel both domestically and internationally