Torrent Pharmaceuticals Limited Gandhinagar Vacancy | BA/ BE Studies

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  • Torrent Pharma R&D is hiring for Chief Investigator (BA/ BE Studies)
  • Position: AGM- BE Centre
  • Job Responsibility:
    • To plan for BA/ BE / Phase I studies and related resources.
    • To ensure compliance with Good Clinical Practice and study protocol during the course of the clinical study.
    • To collaborate with the Institutional Ethics committee (IEC) and provide updates on the study-related information to IEC.
    • To resolve the study-related queries raised by Ethics Committee & regulatory bodies.
    • To approve the study-related documents (i.e Protocol, ICF, CRF) prepared by subordinates.
    • To ensure the GLP compliance of the Biochemical and Clinical Pathology laboratory operations.
    • To ensure volunteer safety and report adverse events (if any).
    • To maintain the investigational product accountability at the site.
    • Coordinate regulatory and ethical issues related to clinical study.
    • To review and approve clinical study reports and related SOPs.
    • To maintain the records of the study at the site.
    • To ensure the appropriateness of the informed consent process and the confidentiality of the volunteers.
    • To ensure the accuracy, completeness, legibility, and timeliness of the data reported to the sponsor in the CRFs and in all required reports.
    •  To manage the Regulatory and Quality Audits (internal & external).
    • To serve as an auditor for the technical evaluation of CRO.
    • To monitor the outsourced clinical studies.
    • To supervise the overall periodic employee health check-up exercise.
    • To review employee health check-up reports and promote preventive healthcare by counselling the employees on a need basis.
    • To liaise with Sponsor for study planning and updates.
  • Qualification & Experience: MD with a minimum of 8 years of relevant experience
  • Location: R&D Center (Gandhinagar)

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