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Sr. Clinical Trial Manager - F/T OR Contract

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San Francisco, CA
$1 - $1
Job Type
Direct Hire
Apr 24, 2017
Job ID
Sr.  Clinical Trial Manager 
San Francisco Bay Area
The Sr. Clinical Trial Manager (Full Time, Onsite OR Contractor - 12 months, Onsite) will oversee and manage all operational aspects of phase I – III clinical trials with minimal oversight from protocol to end.
  • Responsible for leading a cross functional team (or participating as a lead) in the planning and delivery of a defined clinical project to scope, quality, budget, time, managing resource and risk.
  • Responsible for project management including the development and maintenance of realistic, up to date and appropriate quality, project and study plans (including timelines and budget)
  • Contribute to and support selection of all study-related vendors and have vendor oversight.
  • Provide input into study feasibility, study specifications, vendor/partner contracts and essential documents such as clinical study protocols, informed consents, CSRs, etc.
  • Ensures study execution compliance with GCP/ICH and any other regulatory requirements and works cooperatively with Quality Assurance with respect to site audits
  • Manage a clinical study and the associated processes to identify and solve operational issues and drive delivery to plan through internal or external partners (i.e., CROs).
  • Act as operational interface with external (e.g. CRO) partners. Ensure successful delivery of all study lifecycle deliverables (RFP through completion of the Trial Master File).
  • Review and approve contracts, work orders and invoices prior to submission to senior management for approval.
  • Establish and maintain effective communication and collaboration with functional area peers, in order to meet program objectives and support achievement of goals.
  • Responsible for participating and presenting at Investigator Meetings.
  • Oncology experience highly desired
  • 5+ years managing Phase I-III Clinical Trials
Additional Notes:  Salary is very strong for this position.