Clinical Trial Manager - ONCOLOGY

Job type:
on-site
Start:
09/2013
Duration:
12 Months
From:
Real Staffing
Place:
San Francisco
Date:
09/20/2013
Country:
flag_no USA
project ID:
601787

Warning
This project is archived and not active any more.
You will find vacant projects in our project database.
Roles and Responsibilities:
  • Identify, select, and monitor investigational sites for clinical studies; prepare accurate and timely visit reports from all site interaction visits
  • Develop and maintain good working relationships with investigators and study staff
  • Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study-specific manuals and procedures
  • Track and report on progress of study including site activation, patient enrollment, monitoring visits
  • Oversee performance of CROs, third party vendors, and field CRAs including co-monitoring, to ensure compliance with study protocol and in accordance with scope of work; identify areas of concern and escalate to manager or CRO as appropriate
  • Assist in identification and hiring of appropriate CROs and third party study vendors
  • Clinical data review of data listings and summary tables, including query generation


Requirements:
  • BS/RN degree or equivalent
  • Oncology study experience required
  • Demonstrated ability to work independently as well as part of a multi-functional study team
  • Clinical operations work experience in the pharmaceutical industry and working knowledge of GCP/ICH guidelines and the clinical development process


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