职位描述
Learns to serve as a Study Director, as described in the GLPs. Learns 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.
Learns to review cost estimates to ensure that all protocol/amendment driven workscope specifications have been included in the price estimation.
Understands financial status of ongoing studies.
Learns to develop protocols and ensures that the protocol, including any changes, is approved, and is in compliance with appropriate SOPs, GLPs, and regulatory agency guidelines.
Assure that Test systems are as specified in the protocol.
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.
Unforeseen circumstances that may affect the quality and integrity of the nonclinical laboratory study are noted when they occur, and corrective action is taken and documented.
Directs preparation of reports, ensures compliance with protocol and regulatory requirements, and submits them to the client.
All raw data, documentation, protocols, specimens, and final reports are transferred to the archives during or at the close of the study.
Participates in and may host client visits.
In charge of training of the junior study directors.
Oversee the performance of junior study directors in the same group, and communicate with the line manager regularly.
Performs other related duties as assigned
Education/Qualifications:
PhDMS in toxicology or related subject, DVM or equivalent degree. Experience may be substituted for education.
Experience:
