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Clinical Data Manager

Cipla Ltd

Mumbai, Chennai

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2 w

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Full time

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Healthcare

Minimum

$5,00,000 Per Year

Maximum

$18,00,000 Per Year

Position: Clinical Data Manager Our organisation invites applications from accomplished professionals for the role of Clinical Data Manager. This role provides exposure to strategic initiatives and direct collaboration with senior leadership. Primary Duties and Responsibilities: Develop SOPs, work instructions, and training materials for clinical operations teams. Monitor safety signals and liaise with pharmacovigilance teams for adverse event management. Prepare and maintain essential trial documents including protocols, ICFs, and CSRs. Track milestones and coordinate with sites, CROs, and sponsors for on-time delivery. Plan, monitor, and close clinical trials in compliance with GCP and ICH guidelines. Manage medical coding using MedDRA and WHO Drug Dictionary for clinical trial data. Conduct benefit-risk assessments and contribute to clinical development strategy discussions. Support IND, NDA, MAA, and dossier submissions with high-quality regulatory documentation. Required Qualifications: Commitment to ongoing professional learning and industry knowledge enhancement. Bachelor's degree in a relevant discipline; master's degree or professional certification is preferred. Detail-oriented mindset with the ability to synthesise and present complex information clearly. Exceptional organisational skills with the ability to handle multiple concurrent responsibilities. Ability to work both independently and in a team-oriented, collaborative environment. At least 24 years of hands-on experience in a comparable professional setting. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. This role offers exceptional career growth, a collaborative culture, and a compensation structure aligned to market benchmarks.