Clinical Trial Manager

Job type:
on-site
Start:
09/2014
Duration:
temp to hire
From:
Real Staffing
Place:
South San Francisco
Date:
08/28/2014
Country:
flag_no USA
project ID:
766407

Warning
This project is archived and not active any more.
You will find vacant projects in our project database.
Qualified candidates will possess the following experience:
  • 5+ years prior pharmaceutical or biotech sponsor company experience
  • Independent phase III clinical study management
  • Oncology (or other complex indication)
  • Minimum 1 year CRO management experience
  • Minimum 1 year experience managing direct reports
  • International clinical study experience
  • Ability to meet aggressive timelines
  • Budget management
  • Bachelors Degree


Primary Responsibilities include:
  • Provides direction and leadership to global Phase III oncology clinical trial(s)
  • Develops operational plans including site monitoring strategies, trial budgets, site selection, and clinical supplies management
  • Provides the day-to-day operational management of CROs and vendors to ensure delivery against contracted scope of work
  • Oversees the development and maintenance of study specific manuals
  • Contributes to the development and management of the study timelines, resources, and budgets
  • Ensures operational tracking tools are identified, including systems to meet the needs of the operations team and ensures reporting to the Senior Director, Clinical Operations
  • Ensures accurate tracking and reporting of study metrics
  • Provides operational input into the development of protocol feasibility questionnaires
  • Provides clinical operations expertise to ensure operational feasibility and delivery
  • Participates in the forecasting and management of non-clinical supplies to ensure sites have supplies to run clinical study
  • Coordinates with Regulatory Affairs to prepare responses to study questions or issues from Health Authorities or IRBs/IECs
  • Performs ongoing vendor management (e.g., CROs, Central Labs, IVRS, Reading Centers), including independent negotiation of scope of work, budgets, performance management, and issue resolution
  • Ensures study adherence to ICH/GCP and SOPs