Clinical Trial Manager

South San Francisco  ‐ Onsite
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Description

Job Description:
  • Requires minimal supervision to manage various activities associated with multiple clinical studies in accordance with designated project assignments.
  • Uses thorough knowledge of FDA regulations and ICH guidelines to ensure compliance with both during clinical trial conduct.
  • Has had experience as clinical operations co-lead/lead on a significant Phase II or Phase III program.
  • Independently designs study related documents including but not limited to: clinical protocols, case report forms, site study manuals and project tools, monitoring plans, tracking tools, informed consent forms.
  • Support of departmental functions for preparation and/or attendance at departmental meetings, clinical operations training and developmental activities as required and directed.
  • Leads study management team meetings and teleconferences with study vendors.
  • Manages study-specific CROs and vendors and contract CRAs as appropriate.
  • Performs monitoring of sites as required by needs of project with minimal guidance or supervision.
  • Adds insight regarding evaluation and selection of CRO's, contractors and other outside vendors.
  • Coordinates efforts in study start-up, including study feasibility, site selection, preparation and follow-up of site regulatory packages in coordination with other clinical operations staff as appropriate.
  • Works with Financial Operations Coordinator on vendor and study site budget tracking and compliance.
  • Uses well-developed problem-solving skills to address needs of program and may provide guidance to other lower level personnel.


Requirements:
  • BA/BS in science-related field with a minimum of 4 years work experience as a CRA or CRA/CTM combination of relevant related work experience.
  • Cardiology
  • global study experience
  • Vendor management
  • Involvement in protocol development.


To find out more about Real please visit www.realstaffing.com
Start date
04/2014
From
Real Staffing
Published at
09.04.2014
Project ID:
692008
Contract type
Permanent
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