Clinical Trial Manager II

Job type:
on-site
Start:
03/2014
Duration:
n.a
From:
Real Staffing
Place:
South San Francisco
Date:
03/20/2014
Country:
flag_no USA
project ID:
681892

Warning
This project is archived and not active any more.
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The Senior Clinical Trial Manager is responsible for:
  • Activities ensuring high quality deliverables are within budget and timelines.
  • Support cross-functional Study Team within Clinical Operations with minimal oversight from the Sr. CTM and/or CPL.
  • Clinical Operations deliverables to achieve study objectives and milestones within timelines and budget.
  • Responsible for vendor selection and management including CRO, IVRS, central lab and imaging vendor.
  • Provide input to the study budget and is responsible for managing assigned vendor budget(s).
  • Under the leadership of the Sr. CTM, takes responsibility for agreed operational aspects (e.g., vendor management, drug supply management).
  • Identify and track timelines, milestones, critical study activities, issues and budget and provide regular updates to the Study Team and CPL as appropriate.
  • Partner with CPL to develop and/or present at project teams and management review bodies.
  • Obtaining agreement on project timelines, budgets, study objectives, and goals.
  • Ensure relevant functional groups provide input to and participate in developing and finalizing Study Team level documents and meet Study Team level deliverables within timelines.
  • This is not an exhustive list of responsibilities.


Skills/Education
  • Experienced in clinical trial management.
  • Extensive experience in Oncology required.
  • Experience in planning, risk mitigation strategies, trial budgets, site selection, clinical supplies management, conduct and monitoring of clinical studies.
  • Familiar with global trial requirements.
  • 5+ years direct industry study management experience in clinical and drug development
  • Bachelors degree or equivalent undergraduate degree (scientific or healthcare discipline preferred)
  • Working knowledge of international regulatory and ICH GCP guidelines


To find out more about Real please visit www.realstaffing.com