Clinical Trial Manager

Job type:
permanent
Start:
07/2014
Duration:
n.a
From:
Real Staffing
Place:
South San Francisco
Date:
07/12/2014
Country:
flag_no USA
project ID:
740696

Warning
This project is archived and not active any more.
You will find vacant projects in our project database.
Responsibilities
  • Select and manager vendors (e.g. CRO, central lab)
  • Provide input to site selection and oversee site performance
  • Develop and negotiate site budgets
  • Review monitoring reports
  • Provide input to study budget planning and management
  • Prepare study materials, including protocols, laboratory manuals, informed consents, Case Report Forms, monitoring and communication plans
  • Manage clinical trial materials
  • Oversee finalization of data management and statistical analysis plans
  • Review TLFs and clinical study reports
  • Develop timelines to optimize the achievement of study goals and milestones
  • Manager investigational drug supply including labeling, distribution and drug accountability
  • Ensure quality and timely delivery of clinical study data
  • Coordinate activities with other functional groups (Regulatory, Safety, Biostatistics
  • Contribute to project clinical team meetings to provide timely and accurate operational updates, plans and recommendations
  • Contribute to the development and review of Clinical SOPs


Qualifications
  • BA/BS in Life Science or related discipline
  • At least 8 years of experience managing Phase II & III clinical trials
  • Ability to work within a team
  • Excellent communication, interpersonal and team leadership skills
  • Excellent communication skills. Problem solving and negotiation skills a must
  • Attention to detail and highly organized; ability to prioritize multiple tasks
  • Familiarity with multiple EDC platforms is a plus
  • Some travel may be required