Senior Clinical Trial Manager

San Francisco  ‐ Onsite
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Keywords

Description

Primary responsibilities include:
  • Conducts and/or oversees all activities required for selecting, initiating, monitoring and closing investigational sites
  • Serves as a primary contact for internal study team members and external vendors
  • Provides oversight of CRO interactions in the areas of study/project management, monitoring, site management, trial master files, and data management
  • Assists in the preparation of clinical trial documents, including study protocols, amendments, model ICFs, laboratory manuals, CRF completion guidelines, study specific instructions, etc.
  • Provides timely and accurate information to Project Management for program level tracking
  • Participates in evaluating study drug supply requirements and manages the logistical aspects of distributing supplies to the investigational sites
  • Coordinates investigator meetings and develops presentation materials
  • Routinely reviews study data and progress of EDC entry; works with data management and clinical sites to resolve data discrepancies
  • Identifies program/clinical trial risks; proactively suggests and implements mitigation strategies
  • Participates in the evaluation, selection and eventual management of vendors
  • Participates in the preparation and finalization of company SOPs


Skills / Education / Requirements:

Candidates must have a BA or BS desgree with a minimum of five years related clinical operations experience (4 years minimum as a CRA and in a lead role). A strong medical/science background with oncology experience is highly desirable. Prior global trial experience required. Knowledge of GCP/FDA/ICH regulations required.

Candidates MUST live in the San Francisco / Bay Area region.
Start date
08/2014
Duration
24 months
From
Real Staffing
Published at
03.08.2014
Project ID:
752589
Contract type
Freelance
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