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Study Manager (Immunoassay)

We are currently looking for a Study Manager with extensive immunoassay experience to join a leading contract research organisation in Cambridgeshire.

The purpose of a Study Manager is to manage studies in the capacity of a Study Director, Principle Investigator 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.

It is essential that candidates have extensive biochemistry and immunoassay (ELISA, RIA, MSD ECL) experience within industry, as well as a degree of MSc in Biochemistry or a related subject.

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.

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 protocols, SOPs and in compliance with the principles of GLP/GCP.
To work safely and become familiar with the divisional safety procedures and safe working practices within the laboratory and adhere to HASAWA and COSHH
Be proficient in the use of on-line data capture systems and office computers.
Liaise on a day-to-day basis with the Team Leader to effectively plan work and maintain time lines.
To contribute to the sourcing, validating and implementation of new technology.
To be competent in using at least two immunoassay platforms and be receiving training in additional methodology where possible.
Maintain an up to date knowledge of scientific developments.
To write and review SOPs when requested.

To apply for this position, candidates must be eligible to live and work in the UK

Matchtech Group Plc is acting as an Employment Agency in relation to this vacancy.