Study Director I

• General Purpose and Scope:
• Serve as a Study Director, as described in the GLPs. Has overall responsibility for the technical conduct of a study as well as for the interpretation, analysis, documentation, and reporting of results.

• Duties and Responsibilities:
• Coordinates efforts of the study team.
• Develops develop protocols and ensures that the protocol, including any changes, is approved and is in compliance with appropriate SOPs, GLPs, and regulatory agency guidelines.
• Works with client service, program management, and study direction to evaluate project proposals, evaluate feasibility, and provide recommendations to clients.
• Reviews cost estimates to ensure that all protocol/amendment driven workscope specifications have been included in the price estimation.
• Understands financial status of ongoing studies.
• Monitors progress and status of assigned studies. Ensures that all experimental data, including observations of unanticipated responses to the test system, are accurately recorded and verified.
• Directs analysis of data, preparation of reports, ensures compliance with protocol and regulatory requirements, and submits them to the client.
• Reviews the tabulated summaries as requested.
• Leads and sponsors client visits.

• Principal Contacts
• Internal

• Study Director Management, Mentor, Study Toxicologists, Clinical Pathology, Formulations, Large and Small Animal Operations, DLAM, Quality Assurance, Client Services, Program Management, Report Coordination, Statistics
• External

• Client Study Monitors, Client Management, Client Quality Assurance representatives

• Travel Requirements: Yes
• Typically attend one national/international scientific meeting per year.
• May have visit to client facilities.

• Language Skills Required:
• Excellent English speaking, reading and writing skills, including technical documents
• May serve as the mentor for new hired Study Directors or Associate Study Directors
• Performs other related duties as assigned.

Labcorp