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.

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.