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Job Title: Study Manager
Description
Our client is a Contract Research Organisation who currently has an opportunity for a Study Manager. The purpose of a Study Manager is to manage studies in the capacity of a Study Director, Principle Investigator, Analytical Project Manager or Responsible Scientist. Dealing on a daily basis with the day-to-day running of the study and liaising with Sponsors, Study Directors and Analysts to perform the analysis as efficiently as possible.

Responsibilities

  • To supervise general laboratory house keeping
  • To participate as necessary in the conducting of sample handling studies
  • To participate in the conduct of development and validation studies
  • To participate in trouble shooting and problem solving of methods
  • Be competent in the role of Study Director, Principle Investigator, Analytical Project Manager or Responsible Scientist
  • To communicate effectively with the Sponsor and/or Study Director at all stages of the study from enquiry to study finalisation
  • To communicate effectively with analysts at all stages of the study including holding study start-up and study close out meetings
  • To prepare and review authorised methods
  • To be competent in the preparation of study protocols
  • To review and interpret data on completion of analysis and review final study standard, QC and sample data
  • Review laboratory study files and proformas in a timely manner
  • To prepare reports for QA review and address comments according to study timelines
  • To prepare reports for distribution to Sponsors or the Study Director
  • Responsible for study archiving on report finalisation
  • To perform all studies within the guidelines of the study.
Candidate requirements
  • Immunoassay based experience essential
  • Organised/Time management
  • Study management experience essential. Experience of Study Directing preferable
  • Line Management experience desirable
  • Experience of working in a GxP environment essential
  • The position requires a degree in a relevant scientific discipline.
Please note that only candidates with EU work authorisation will be considered.
Details
Post Date: 03/11/2009
Hours: Full Time
Location: United Kingdom
Working Term: Permanent Position
Salary: £25,000 to £30,000
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