have you had experience of managing studies and experience of working to regulations?
Want to work for a company who work together to build a healthier and Safer world?
If this sounds like you, Envigo are looking for a Study Manager to join our growing Biomarkers, Bioanalysis and Clinical (BBC) team in Alconbury, Cambridgeshire. Envigo provides essential products and research services for pharmaceutical, crop protection, chemical companies, universities, governments, research organizations.
You will be responsible for the management of analytical studies/phases of studies in the capacity of a Study Director, Project Manager or Principal Investigator, ensuring that all work is conducted in accordance with the Protocol/Plan, (Standard operating Procedures) SOPs and appropriate regulatory standards (Good Laboratory Practice/ Good Clinical Practice) (GLP/GCP).
As a Study Manager, your main responsibilities will be:
- Undertake the role of Study Director, Project Manager or Principal Investigator on analytical studies/phases of studies including but not limited to:
- Protocol/Plan, amendment and File Note preparation
- Scheduling of the work (in conjunction with the Team Leader)
- Maintenance of Master Schedule
- Analytical method preparation
- QC checking
- Interpretation of data
- Responding to QA comments
- Report preparation, amendment, issue and finalisation
- Archiving of studies
- Ensure all work is conducted in accordance with the Protocol/Plan, SOPs and appropriate regulatory standards (GLP/GCP)
- Undertake method development, method validation and sample analysis where required
- Assist in the preparation/amendment of SOPs
- Train staff where requested
- Work safely in accordance with HASAWA. Ensure risk assessments and COSHH assessments are in place for procedures undertaken and materials in use on assigned studies
- Manage the day-to-day activities associated with assigned studies
- Supervise analytical staff where requested
- Contribute to the performance review of analytical staff where requested
- Provide study progress updates to Sponsors on a regular basis
- Attend Sponsor meetings for assigned studies
- Prepare contact reports when attending teleconferences and Sponsor meetings
The ideal candidate will have
- Degree or higher in a biological subject or equivalent experience
- Experience of study/ project management in a regulated environment
Interested? Then apply today to join Envigo and help us achieve our mission - to be the best company to work with and the best company to work for!!
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