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Senior ADME Study Manager

Location: Rushden
Salary: Competitive
Ref: ALS 2180

On behalf of our client, we are looking to recruit a Senior ADME Study Manager to conduct and study direct metabolism studies for new product development based on global regulatory requirements.

Basic Requirements:

  • BSc in a life science subject
  • Previous experience of conducting Metabolism/ADME studies in a GLP environment
  • Ability to manage and lead teams
  • Commercial understanding and ability to manage finances

Duties and Responsibilities:

  • Act as Study Director, Analytical Project Manager and/or Principal Investigator on a wide range of metabolism 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
  • 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 and scientifically review reports written by other Study Directors.
  • Review proposals ensuring all costs are included and revenue recognition milestones are clear.
  • Work with Team Leader to prepare and maintain a library of generic study plans, template reports and cost builds for their area. Track actual vs budgeted hours on assigned studies ensuring any necessary changes are made to generic documents
  • Mentor more junior Study Directors.
  • As a recognised expert in a metabolism specialism increase profile of the department externally through playing an active role in expert groups, networking and publications
  • Comply with Good Laboratory Practice, Good Clinical Practice and/or Good Manufacturing Practice requirements whenever appropriate to the work being undertaken.

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.