Pharma Clinical Operations Job @ Cipla Ltd


Cipla Ltd Pharma Clinical Operations Job - Candidates Apply Online

Pharma Clinical Operations Job @ Cipla Ltd – Candidates Apply Online

Cipla Ltd Pharma clinical operations member vacancy. B Pharma job opening 2022. Clinical operations job opening 2022. B Pharma job vacancy 2022. Candidates with a bachelor’s degree in pharma may apply for the job vacancy for the post of clinical operations team member at Cipla Ltd. Intrested and eligible candidates may check out all the details on the same below:

Job Title: Team Member – Clinical Operations (68326)

Location: India – Maharashtra – Vikhroli

Elibgility Criteria:

B. Pharm/B.Sc. For clinical B. Pharma or M.Sc is compulsory.M. V. Sc. (Pharmacology and Toxicology) is desirable for preclinical

Experience:

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 minimum 2 years of practical experience

Competencies/Skills

  • Communication Skills (clarity of thought, comprehension)
  • Likely potential for growth
  • Job / Product / Technical Knowledge / Pharma domain knowledge
  • Presentation & Interpersonal skills (If applicable)
  • Managerial or People Management skills
  • Safety awareness (If applicable)
  • Relevance of Previous Experience
  • Comprehension, Analytical & Problem-solving abilities
  • Productivity & Result Orientation (If applicable)
  • Attitude
  • Qualification fitment
  • Sales drive (If applicable)
  • Personality traits (Individualistic / Team player, Outspoken, Maturity level, etc.)

Job Purpose

Execute, monitor, report, and interpret preclinical, clinical, and BABE 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, etc. by toxicological review and derivation (Only for preclinical)

Accountabilities

I. Gather preclinical/ clinical/ BABE study outline data by understanding the specific regulatory requirements and project constraints to ensure the successful conduct of studies/trials cost-effectively and within timelines

II. Check CROs for conducting preclinical/ clinical/ bioequivalence studies by site feasibility/ selection visits or evaluation for ensuring adequate facility, skill, and experience for conducting the studies as per requirements

III. 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

IV. 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

V. Monitor and/or audit ongoing studies at CROs to ensure satisfactory conduct as per requirements (guidelines, regulatory, study-specific, etc.) and project timelines

VI. 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

VII. Identify health hazards and assess the 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 the preclinical team)

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