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Contract Clinical Trial Manager

  • Job type: Contract
  • Location: South San Francisco
  • Salary: Depending on Experience
  • Job reference: JANN
  • Sector: Clinical, Clinical Operartions, EPM Scientific
  • Date posted: 12/08/2017
A small biotech company is looking for an experienced Contract Clinical Trial Manager to join their team on a 12 month contract. They are working on Phase II and III Oncology Studies and are looking for someone with strong CRO/Vendor Management

Responsibilities include but not limited to:
  • Support and manage study activities, including investigator recruitment and selection, study start-up, enrollment, data collection, drug projections, and reports.
  • Manage study sites and train clinical site staff to ensure protocol and regulatory compliance.
  • Participate in CRO selection, development of RFPs, budget negotiations, and CRO management.
  • Responsible for clinical site budget and contract negotiation.
  • Planning, monitoring, and managing budgets for clinical studies.
  • Participate and provide guidance for monitoring plans, coordinating study reports, sections for Investigator's Brochures, and regulatory documents (e.g., IND, NDA or BLA).
  • Interact with investigators and thought leaders for protocol development, presentations and publications.
  • Participate in monitoring visits, including Site Qualification and Site Initiation, as needed.
  • Review and support development of SOPs and guidelines for compliance with global regulatory requirements, including establishing appropriate processes and procedures to conduct global clinical trials.

Looking for a candidate with the following background:

  • Strong planning and organizational skills with ability to multi-task and plan activities as they relate to the management of clinical trials, ability to problem-solve
  • Experience managing or supporting management of Phase II-III clinical trials 
  • Bachelors required (advanced degree preferred) with at least 3 years experience in clinical operations program management 

If interested, please reach me at apply.a33ho1ghes2@epmscientific.aptrack.co.uk.
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