Job Reference: J5630613
Updated On: 03/05/2019
Status: Open to Applications
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Role OverviewWe are currently looking for a Senior Study Manager in Metabolism to join a leading CRO company based in the Northamptonshire area. As the Senior Study Manager you will be responsible for the management of metabolism studies, specifically ADME pharmacology studies (Absorption, Distribution, Metabolism and Excretion). Your aim will be to ensure the smooth running and compliance of studies that asses the pharmacological activity of drug compounds as specified by clients.
Key Duties and ResponsibilitiesYour duties as the Senior Study Manager will be varied however the key duties and responsibilities are as follows:
1. Conduct and act as Study Director, Analytical Project Manager and/or Principal Investigator on metabolism studies for new product development based on global regulatory requirements.
2. 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.
3. Prepare study plans, amendments, file notes and deviations as required as well as worksheets to coordinate experimental activities.
4. Review data obtained and prepare study updates and study data for discussion internally and for communication to the client/inclusion into reports.
Role RequirementsTo be successful in your application to this exciting opportunity as the Senior Study Manager we are looking to identify the following on your profile and past history:
1. Relevant degree in a Life Sciences discipline (e.g. Biology, Pharmacology, Biochemistry etc.) is necessary for your application.
2. Proven industry experience in conducting Metabolism/ADME studies in a GLP environment will be essential.
3. A working knowledge and practical experience of Study Directing Metabolism studies in the pharmaceutical or CRO industry will be highly beneficial.
Key Words: Study Manager | Study Director | Metabolism | ADME | PK | TK | Pharmacology | Cytochrome P-450 | DDI | DMPK | Cell based assays | GLP | CRO
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