Clinical Program Manager

Newark  ‐ Onsite
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Keywords

Description

Responsibilities:
  • Executes clinical trials by directing a multi-functional study team.
  • Ensures that timelines, budget and quality are met by partnering with Clinical Operations and Project management.
  • Actively participates in CRO, site and vendor selection to ensure that trial responsiblitites are delegated.
  • Provides mentorship, supervision and training to Clinical Operations Staff involved in the study.
  • Leads the planning and execution of Investigator Meetings.
  • Resolves issues involved with the onboarding and initiation of clinical sites as well as monitors and reports on the site initiation progress.
  • Supervises site monitoring, reviews monitoring, and participates in site auditing.
  • Ensures the study team is up-to-date on program status and priorities.
  • Assuring that the trial is being conducted consistently across countries and sites by developing monitoring plans, manuals, and training manuals.
  • Assists with the writing of clinical protocols, Investigator Brochures and annual IND reports.


Education/Experience Required:
  • Bachelor's degree in a scientific field
  • 7+ years of clinical trial experience (at least 4 years of independent trial Management experience with a Sponsor company
  • Independent site monitoring and management experience
  • Broad knowledge of clinical drug development processes


To find out more about Real please visit www.realstaffing.com
Start date
04/2014
From
Real Staffing
Published at
02.04.2014
Project ID:
687821
Contract type
Freelance
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