Cipla Hiring for Team Member – Clinical Operations @Maharashtra

Location: Vikhroli, Maharashtra, India
Req ID: 86072
Division: IPD
Department: IPD
Employment Type: Permanent

Job Purpose

• Execute, monitor, report, and interpret preclinical, clinical, and BABE 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).

Key Responsibilities

1. Study Data Collection: Gather preclinical, clinical, and BABE study outline data by understanding specific regulatory requirements and project constraints to ensure successful conduct of studies/trials cost-effectively and within timelines.
2. CRO Evaluation: Check CROs for conducting preclinical, clinical, and bioequivalence studies through site feasibility/selection visits or evaluation to ensure adequate facilities, skills, and experience.
3. Protocol Preparation: Liaise with CROs and internal teams to enable preparation, review, and finalization of study protocols as per the defined strategy, ensuring approval by all relevant stakeholders, Ethics Committees, and/or Regulatory authorities within targeted timelines.
4. Sample Procurement: Ensure procurement and dispatch of Innovator samples/RLD and availability of test formulations along with relevant documents (like COA, GMP statements, batch size information, etc.) before study initiation.
5. Study Monitoring: Monitor and/or audit ongoing studies at CROs to ensure satisfactory conduct as per requirements (guidelines, regulatory, study-specific, etc.) and project timelines.
6. Project Coordination: Act as the project coordinator for the entire study by liaising with internal team members, cross-functional teams, CROs, and Project Managers to align all stakeholders and successfully conduct the BE study.
7. Health Hazard Identification: Identify health hazards and assess risks of pharmaceuticals/chemicals/intermediates/impurities through toxicological review and derivation of PDE (permitted daily exposure)/OEL (occupational exposure limit)/TTC (Threshold of toxicological concern) for pharmaceuticals/chemicals (only for preclinical team).

Qualifications

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

Skills and Competencies

• Collaborate to Succeed
• Innovate to Excel
• Perform with Accountability
• Lead with Empathy
• Act with Agility
• Strong Domain Knowledge
• People Management

Job Location: Vikhroli, Maharashtra, India

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