- 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)
Interested candidates may share their CVs on devalmodi@torrentpharma.com