Study Director

MedPharm•Durham, NC

23h

About The Position

Position Summary 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. Essential Functions Provide strategic and technical oversight on studies. Collaborates on continuous process improvement opportunities. To draft study plans and contribute to the preparation of reports for sponsors. For any studies performed according to GLP, act as Study Director to assure that: The study protocol (plan), including any change, is approved and is followed. All experimental data including observations of unanticipated responses of the test system are accurately recorded and verified. Unforeseen circumstances that may affect the quality and integrity of the study are noted when they occur, and corrective action is taken and documented. Test systems are as specified in the study protocol (plan). GLP regulations are followed where appropriate. All raw data, documentation, protocols, specimens and final reports are transferred to the archives during or at the close of the study. To adhere to MedPharm’s Procedures. Contribute to the preparation and review of SOPs and Forms where applicable. Where applicable, promptly record all data according to Good Documentation Practices. Review literature in preparation for studies and to regularly update knowledge by reviewing appropriate literature. Supervisory Responsibilities - This position may be responsible for training, assisting or assigning tasks to others. Any other duties and/or tasks that may be assigned.

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

Supervise and coordinate activities of client projects
Identify areas of improvements and develop new processes
Lead and manage the execution of assigned studies
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 to assure study protocol is followed
Ensure all experimental data is accurately recorded and verified
Document unforeseen circumstances and corrective actions
Ensure test systems are as specified in the study protocol
Follow GLP regulations where appropriate
Transfer all data, documentation, protocols, specimens and final reports to the archives
Adhere to MedPharm’s Procedures
Contribute to the preparation and review of SOPs and Forms where applicable
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