Position: Team Member – Clinical/Pre-Clinical/BA-BE

Job Description

Job Purpose:

• Execute, monitor, report, and interpret preclinical, clinical, and BA-BE studies at CROs.
• 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 (only for preclinical).

Accountabilities:

1. Study Outline Data Collection: Understand specific regulatory requirements and project constraints to ensure successful and cost-effective studies/trials within timelines.
2. CRO Evaluation: Check CROs for conducting studies through site feasibility/selection visits or evaluation to ensure adequate facilities, skills, and experience.
3. Protocol Finalization: Liaise with CROs and internal teams to prepare, review, and finalize study protocols ensuring approval from all relevant stakeholders, Ethics Committee, and Regulatory authorities within timelines.
4. Procurement and Dispatch: Ensure procurement and dispatch of Innovator samples/RLD and availability of test formulation along with relevant documents before study initiation.
5. Study Monitoring/Auditing: Monitor and/or audit ongoing studies at CROs to ensure satisfactory conduct as per requirements and project timelines.
6. Project Coordination: Act as the project coordinator, liaising with internal team members, cross-functional teams, CROs, and Project Managers for successful study conduct.
7. Risk Assessment: Identify health hazards and assess risks of pharmaceuticals/chemicals/intermediates/impurities through toxicological review and derivation of PDE/OEL/TTC (only for preclinical team).

Candidate Profile

• Qualifications:
  • BA-BE Studies: B. Pharm/B.Sc.
  • Clinical Studies: B. Pharm or M.Sc. or M.B.B.S.B. V. Sc. & A.H. is compulsory.
  • Preclinical Studies: M. V. Sc. (Pharmacology and Toxicology) is desirable.
• Experience:
  • Minimum 2 years in handling BA/BE or Clinical Research operations with knowledge of regulatory guidelines.
  • Minimum 2 years in preclinical pharmacology and toxicology with practical experience.

Additional Information

• Experience: 2 years
• Qualification: B. Pharm/B.Sc. for BA-BE; B. Pharm, M.Sc., M.B.B.S.B. V. Sc. & A.H for clinical; M. V. Sc. (Pharmacology and Toxicology) for preclinical desirable.
• Location: Maharashtra – Vikhroli
• Industry Type: Pharma / Healthcare / Clinical research
• Functional Area: Clinical/Pre-Clinical/BA-BE
• End Date: 20th July 2024

Interested candidates with the relevant qualifications and experience are encouraged to apply before the end date.

Application Link