Study Director
About The Position
A Study Director has the responsibility to supervise and coordinate activities of client projects; identify areas of improvements and develop new processes; lead and manage the execution of assigned studies. This role provides strategic and technical oversight on studies, collaborates on continuous process improvement opportunities, and drafts study plans and contributes to the preparation of reports for sponsors. For studies performed according to GLP, the Study Director assures that the study protocol is approved and followed, experimental data is accurately recorded and verified, unforeseen circumstances are noted and addressed, test systems are as specified, GLP regulations are followed, and all raw data, documentation, protocols, specimens, and final reports are transferred to archives. The role also involves adhering to company procedures, contributing to SOPs and Forms, promptly recording data according to Good Documentation Practices, and reviewing literature to update knowledge. This position may be responsible for training, assisting, or assigning tasks to others, and performing any other assigned duties.
Requirements
- Bachelor’s degree in relevant scientific field (e.g. Chemistry, Biology, etc.)
- 3-5 years of relevant experience
- Proficiency in technical writing
- Must be able to analyze data sets and interpret results
- Proficiency with Microsoft Office (Word, Excel, PowerPoint, Teams, etc.) required.
Nice To Haves
- Familiarity with JMP is a plus, but not required
Responsibilities
- Provide strategic and technical oversight on studies.
- Collaborate on continuous process improvement opportunities.
- Draft study plans and contribute to the preparation of reports for sponsors.
- Act as Study Director for studies performed according to GLP to assure protocol adherence, accurate data recording and verification, documentation of unforeseen circumstances and corrective actions, correct test systems, adherence to GLP regulations, and proper transfer of all study materials to archives.
- Adhere to MedPharm’s Procedures.
- Contribute to the preparation and review of SOPs and Forms where applicable.
- Promptly record all data according to Good Documentation Practices.
- Review literature in preparation for studies and to regularly update knowledge.
- Train, assist, or assign tasks to others.
- Perform any other duties and/or tasks that may be assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
