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Study Manager Immunoassay

Study Manager Immunoassay
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.
You will:-
• 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

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

Qualifications
• The position requires a degree in a relevant scientific discipline.

Salary Up to £30,000 based in Cambridgeshire