Study Manager

LOCATION: Rushden       SALARY: Competitive      REF: ALS 2491

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On behalf of our client, we are looking to recruit a Study Manager to direct a range of Metabolism studies (e.g., clinical metabolism mass balance, ADME, Biologics, dermal penetration) for new product development based on global regulatory requirements.

You will be based in a cutting edge, fully integrated pharma-based R&D service platform supporting the life sciences industry, with a company that has invested in its people and facilities.

Basic Requirements:

  • PhD, MSc or BSc in Chemistry, Biochemistry, or related subject.
  • Deep knowledge of clinical and non-clinical metabolism studies.
  • Experience of working in Metabolism laboratory.
  • Experience of Study Directing in GLP/GCP facility
  • Experience of working with Radioactivity (14C/3H)
  • Proficiency in analytical techniques such as HPLC/TLC/LC-MS.
  • Understanding of the drug/ agrochemical development process.
  • Coaching & Mentoring staff, as well as being committed to self-development and learning.

Duties and Responsibilities:

  • Act as Study Director, Analytical Project Manager and/or Principal Investigator on a wide range of Metabolism studies such as dermal penetration, Biologics, and ADME.
  • 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 on the month, flagging up any issues early. Ensure resource allocated to their studies is effectively utilised.
  • Review data obtained and prepare the 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.
  • Effectively communicate with clients regarding study progress and address client comments.
  • Increase profile of the department externally by publishing papers/posters and participation in expert groups.
  • 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.
  • Address findings arising from QA audits and process inspections.

Agenda only recruits 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.


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