Study Manager - Metabolism
Ref: ALS 2250
On behalf of our client, we are looking to recruit a Study Manager to project manage a range of Metabolism studies for new product development based on global regulatory requirements.
- Degree in Chemistry, Biomedical Sciences or a related subject
- Experience of working in a metabolism laboratory
- Previous experience study directing in a GLP facility
- Direct experience in key analytical procedures to perform metabolism studies, to include: dose formulation and assessment, sample extraction, HPLC analysis
- Experienced in supervision of metabolism studies, preferably in vivo studies
- Strong knowledge of clinical and non-clinical metabolism studies
Duties and Responsibilities
- 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
- Take full responsibility for the conduct of experimental work required to successfully fulfil all requirements 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.
- Review data obtained and prepare study plans, updates and data for discussion internally and for communication to the client/inclusion into reports.
- Address findings arising from QA audits and process inspections.
- 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.
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.