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Clinical Data Manager

Glenmark

Chennai, Mumbai

·

3 w

·

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 is looking for an ambitious Clinical Data Manager committed to quality outcomes and sustained growth. This is an opportunity to be part of a purpose-driven team reshaping industry standards and best practices. Primary Duties and Responsibilities: Plan, monitor, and close clinical trials in compliance with GCP and ICH guidelines. Monitor safety signals and liaise with pharmacovigilance teams for adverse event management. Conduct benefit-risk assessments and contribute to clinical development strategy discussions. Support IND, NDA, MAA, and dossier submissions with high-quality regulatory documentation. Manage medical coding using MedDRA and WHO Drug Dictionary for clinical trial data. Develop SAS programs for SDTM/ADaM dataset creation and table, figure, listing generation. Provide clinical site training on data collection standards and regulatory requirements. Prepare and maintain essential trial documents including protocols, ICFs, and CSRs. Required Qualifications: Bachelor's degree in a relevant discipline; master's degree or professional certification is preferred. Proficiency in relevant software and digital tools specific to the functional area. 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. Detail-oriented mindset with the ability to synthesise and present complex information clearly. Exceptional organisational skills with the ability to handle multiple concurrent responsibilities. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. We value talent and invest in our people this role offers both professional challenge and meaningful rewards.