Study Director- toxicology 毒理专题负责人
科文斯医药研发有限公司ShanghaiUpdate time: August 28,2019
Job Description

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:

  • One to two years of related experience.

  • Skilled in performing scientific presentations and preparing scientific publications


职能类别: 生物工程/生物制药

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