Bioanalysis Senior Study Manager
Ref: ALS 2164
On behalf of our client, we are looking for a Bioanalysis Senior Study Manager to conduct and/or study direct metabolism studies for new product development based on global regulatory requirements.
- BSc or PhD in a relevant life science subject
- Previous experience of leading, coordinating and managing metabolism studies is essential
- A background of managing GLP compliant studies is essential
- Experience in a CRO/pharmaceutical environment is strongly desired
Duties and Responsibilities
- Act as Study Director, Analytical Project Manager and/or Principal Investigator on a wide range of metabolism studies
- Study Direct more complex studies/bespoke new study types
- 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
- Review data obtained and prepare study updates and study data for discussion internally and for communication to the client/inclusion into reports
- 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. Ensure work scope changes are flagged to management
- Comply with Good Laboratory Practice, Good Clinical Practice and/or Good Manufacturing Practice requirements whenever appropriate to the work being undertaken
- Mentor junior Study Directors.
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.