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Clinical Data Manager

Tata consultancy services

Mumbai, Hyderabad

·

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 An exciting career opportunity exists for a motivated Clinical Data Manager to advance their professional journey. This role sits within a fast-paced, innovation-driven organisation that values integrity and continuous improvement. Principal Responsibilities: Review source data and ensure completeness, accuracy, and regulatory compliance. Prepare and maintain essential trial documents including protocols, ICFs, and CSRs. Manage medical coding using MedDRA and WHO Drug Dictionary for clinical trial data. Monitor safety signals and liaise with pharmacovigilance teams for adverse event management. Provide clinical site training on data collection standards and regulatory requirements. Support IND, NDA, MAA, and dossier submissions with high-quality regulatory documentation. Develop SAS programs for SDTM/ADaM dataset creation and table, figure, listing generation. Plan, monitor, and close clinical trials in compliance with GCP and ICH guidelines. Candidate Requirements: Sound understanding of organisational dynamics and stakeholder management in complex environments. Leadership experience with a track record of guiding teams, projects, or cross-functional initiatives. Advanced competency in analytical tools, reporting platforms, and role-specific technology. Critical and strategic thinking skills with the ability to translate insights into clear actions. Commitment to professional ethics, confidentiality, and the highest standards of conduct. Recognised qualification in the relevant professional field at the undergraduate or graduate level. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. The organisation provides a comprehensive benefits package and excellent career advancement opportunities for the right candidate.