Execute, monitor, report, and interpret preclinical, clinical, and BABE (Bioequivalence) studies at CROs to support various regulatory submissions within targeted timelines, budgets, quality, and regulatory guidelines. Identify health hazards and assess risks associated with pharmaceuticals/chemicals/intermediates/impurities through toxicological review and derivation (specifically for preclinical studies).
Accountabilities:
- Gather preclinical/clinical/BABE study outline data to ensure successful conduct of studies/trials cost-effectively and within timelines.
- Evaluate CROs for capability to conduct studies, ensuring adequate facilities and expertise.
- Liaise with CROs and internal teams for study protocol preparation, review, and approval.
- Ensure procurement and dispatch of Innovator samples and test formulations before study initiation.
- Monitor ongoing studies at CROs to ensure compliance with guidelines and timelines.
- Act as project coordinator, aligning stakeholders and overseeing the entire study process.
- Conduct toxicological reviews and derive exposure limits for pharmaceuticals/chemicals (preclinical focus).
Education Qualification:
- For BABE: B.Pharm/B.Sc.; For Clinical: B.Pharm/M.Sc./M.B.B.S./B.V.Sc. & A.H. Compulsory; M.V.Sc. (Pharmacology and Toxicology) desirable for preclinical.
Relevant Work Experience:
- 2 years in BA/BE or Clinical Research operations with knowledge of regulatory guidelines.
- 2 years in preclinical pharmacology and toxicology, including practical experience.
