My client, a global drug discovery organisation, are looking for a Study Manager to join them on their Metabolism team. The Study Manager will project manage a range of Metabolism studies (e.g. clinical metabolism mass balance, ADME, Biologics, dermal penetration) for new product development based on global regulatory requirements.
The responsibilities of the Study Manager are:
• Act as Study Director, Analytical Project Manager and/or Principal Investigator on a range of Metabolism studies (e.g. clinical metabolism mass balance, ADME, Biologics, dermal penetration) studies.
• Take full responsibility for the conduct of experimental work required to successfully fulfil all the requirements of a study to the timelines stated in the Study Plan.
• Plan work to ensure revenue recognition milestones on assigned studies are hit in the month, flagging up any issues early. Ensure resource allocated to their studies is effectively utilised.
• Prepare study plans, amendments, file notes and deviations as required.
• Prepare worksheets to coordinate experimental activities.
• Calculate and QC check data.
• Review data obtained and prepare study updates and study data for discussion internally and for communication to the client/inclusion into reports.
• Prepare study reports.
• Address findings arising from QA audits and process inspections.
• Effectively communicate with clients regarding study progress and address client comments.
• Supervise, mentor and/or train more junior members of staff.
• Review cost builds for assigned studies with Team Leader, track actual vs budgeted hours providing feedback where changes to cost builds are necessary. Ensure any potential work scope changes are flagged to management.
• Increase profile of the department externally by publishing papers/posters and participation in expert groups.
The ideal candidate for the Study Manager will need to have:
• A PhD, MSc or BSc (Hons) in Chemistry, Biochemistry , Biomedical Sciences or related subject
• Experience of working in Metabolism laboratory
• Experience of Study Directing in a GLP/GCP facility
• Experience of working with Radioactivity (14C /3H)
• Deep knowledge of clinical and non-clinical Metabolism studies
• Project Management
• Proficiency in analytical techniques (HPLC/TLC/LC-MS)
• Understanding of the drug/agrochemical development process
Keywords: Metabolism, Study Manager, Study Director, Principal Investigator, HPLC, GLP