Cipla Hiring Team Member - Clinical Operations
Introduction
Cipla, a global pharmaceutical leader, is seeking a highly motivated Team Member for Clinical Operations. This role, based in Vikhroli, Maharashtra, is ideal for B. Pharm/B.Sc. graduates with at least 2 years of experience in clinical research operations. If you have a strong background in handling BA/BE studies and knowledge of regulatory guidelines, this could be the perfect opportunity for you.
About Cipla
Cipla is dedicated to ensuring affordable and accessible healthcare for patients around the world. Known for its high-quality standards and ethical business practices, Cipla offers a dynamic and inclusive work environment where innovation and collaboration thrive.
Job Purpose
The primary purpose of this role is to execute, monitor, report, and interpret preclinical, clinical, and BABE studies at CROs (Contract Research Organizations). The successful candidate will support various regulatory submissions within targeted timelines, budgets, and quality standards. Additionally, this role involves identifying health hazards and assessing risks associated with pharmaceuticals, chemicals, intermediates, and impurities through toxicological review and derivation.
Key Responsibilities of Cipla Team Member - Clinical Operations
- Gather preclinical/ clinical/ BABE study outline data by understanding the specific regulatory requirements and project constraints to ensure successful conduct of studies/trials cost effectively and within timelines
- Check CROs for conducting preclinical/ clinical/ bio equivalence studies by site feasibility/ selection visits or evaluation for ensuring adequate facility, skill and experience for conducting the studies as per requirements
- Liaise with CROs and internal team to enable preparation, review, and finalization of study protocol as per the defined strategy to ensure that protocol is approved by all relevant stakeholders, Ethics Committee, and/or Regulatory authorities within targeted timelines
- Ensure procurement and dispatch of Innovator samples/ RLD and availability of test formulation along with relevant documents (like COA, GMP statements, batch size information etc.) before study initiation
- Monitor and/or audit ongoing studies at CROs to ensure satisfactory conduct as per requirements (guidelines, regulatory, study specific, etc.) and project timelines
- 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
- Identify health hazard and assess risk of pharmaceuticals/ chemicals/ intermediates/ impurities, etc. by 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)
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Qualifications required to apply Team Member - Clinical Operations
- Education: B. Pharm/B.Sc. for BABE; B. Pharma or M.Sc. or M.B.B.S.B. V. Sc. & A.H for clinical studies.
- Desirable: M. V. Sc. (Pharmacology and Toxicology) for preclinical studies.
Relevant 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 practical experience.
Competencies and Skills
- Collaborate to Succeed
- Innovate to Excel
- Perform with Accountability
- Lead with Empathy
- Act with Agility
- Strong Domain Knowledge
- People Management
Job Location
- Location: Vikhroli, Maharashtra, India
- Shift Hours: Full-time
How to Apply for Team Member - Clinical Operations
If you are passionate about making a difference in the pharmaceutical industry and meet the qualifications, apply online at
Cipla Careers.
https://pharmastuff.org.in/job/cipla-hiring-team-member-clinical-operations
