1 General Purpose and Scope:
- Serves 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.
2 Duties and Responsibilities:
- Coordinates efforts of the study team.
- Develops 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.
- Peer reviews protocols and reports for other Study Directors.
- Serves as a mentor to newly hired Study Directors or Associate Study Directors.
- Performs scientific mentoring activities (e.g.; training study specific techniques, assisting with complex analytical work/problem solving, and presenting technique seminars).
- Provides a leadership role in troubleshooting and solving challenging technical problems.
- Implements and validates new techniques and instrumentation to improve operations, when needed
- May lead a scientific team to conduct complex and challenging feasibility/development studies.
- Contributes to long-range planning and technical policies of the department.
- Performs other related duties as assigned.
Excellent communication skill in both English and Chinese.
PhD in toxicology or related subject, DVM or equivalent degree preferred. Experience may be substituted for education.
Three to five years of related experience for PhD, and five to seven years of related experience for Master. Relevant experience may be substituted for years of related experience.
Diplomate, ABT certification desirable.
Skilled in performing scientific presentations and preparing scientific publications.
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