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Job Details

Study Manager - ADME

Location: Northamptonshire
Salary: Competitive
Ref: ALS 2262

On behalf of our client, we are looking to recruit a Study Manager to direct a wide range of non-clinical ADME, clinical ADME, livestock and veterinary metabolism studies for new product development in compliance with global regulatory requirements.

Basic Requirements

  • BSc or MSc in Chemistry, Biochemistry or a related subject
  • Previous experience working in a Metabolism laboratory in a CRO, pharmaceutical, agrochemical or veterinary medicine company
  • Experience of study directing in a GLP facility
  • Proficiency in analytical techniques, such as HPLC, TLC and LC-MS
  • Extensive knowledge of animal metabolism studies
  • Experience of working with radioactivity
  • Skilled in scientific data interpretation, reporting, and presentation

Duties and Responsibilities

  • Act as Study Director and Principal Investigator on a wide range of non-clinical ADME, clinical ADME and livestock metabolism studies
  • Take full responsibility for the conduct or experimental work required to successfully fulfil all the requirements of a study to the timelines stated in the Study Plan
  • Prepare study plans, amendments, file notes and deviations as required
  • Prepare worksheets to coordinate experimental activities
  • Calculate and QC check data
  • Plan work to ensure revenue recognition milestones on assigned studies are achieved and ensure resource allocated to their studies is effectively utilised
  • Address findings arising from QA audits and process inspections
  • Review data obtained and prepare study updates and study data for discussion internally and for communication to the client/inclusion into reports
  • 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 

Agenda and its clients only recruit people who are passionate about animal care and welfare, people with integrity who are honest and trustworthy and who have a great work ethic.  To enable us to hire the very best people we will conduct a full and comprehensive background and pre-employment screening as an essential part of the recruitment process.