Senior Clinical Trial Manager

San Mateo  ‐ Onsite
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Keywords

Description

Primary Responsibilities:
  • Accountable for Clinical Operations deliverables to achieve study objectives and milestones within timelines and budgets
  • Responsible for Phase I Unit site selection / CRO vendor management and oversight
  • Independently lead cross-functional early phase CRO / study teams (facilitate study team-CRO communication across various internal science, clinical, operational and technical functions)
  • Provide input to the program budget and is accountable for managing overall study budget
  • Conduct protocol and site feasibility assessments
  • Provide drug supply assumptions to clinical planning team
  • Provide support, mentoring, and study-specific training to Clinical Operations staff


Skills / Experience:
  • 6-8+ years study management experience in clinical and drug development, including managing and partnering with Early Phase CRO's to deliver a broad range of CRO services
  • Highly experienced in managing early development phase clinical studies and experienced in clinical research/development
  • Effective leadership of multiple cross-functional study teams
  • Demonstrated experience in various therapeutic areas; experience in conducting healthy volunteer ClinPharm or Phase I dose escalation studies
  • Excellent planning, delegation, and organizational skills
  • Familiar with global trial requirements
  • Highly effective verbal and written communication skills in English
  • Working knowledge of international regulatory and ICH GCP guidelines


Education: Bachelors degree or equivalent required (scientific or healthcare discipline preferred)

To find out more about Real please visit www.realstaffing.com
Start date
01/2014
Duration
17 months
From
Real Staffing
Published at
22.12.2013
Project ID:
643734
Contract type
Freelance
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