Senior Clinical Data Manager
Tata consultancy services
Delhi, Bangalore
·2 w
·Full time
·Healthcare
$5,00,000 Per Year
$18,00,000 Per Year
Position: Senior Clinical Data Manager An exciting career opportunity exists for a motivated Senior Clinical Data Manager to advance their professional journey. This role sits within a fast-paced, innovation-driven organisation that values integrity and continuous improvement. Main Accountabilities: Manage medical coding using MedDRA and WHO Drug Dictionary for clinical trial data. Review source data and ensure completeness, accuracy, and regulatory compliance. Maintain trial master files and ensure ongoing audit-readiness and regulatory compliance. Monitor safety signals and liaise with pharmacovigilance teams for adverse event management. Provide clinical site training on data collection standards and regulatory requirements. Develop SAS programs for SDTM/ADaM dataset creation and table, figure, listing generation. 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. Essential Skills and Experience: Strong project management capabilities with experience in agile or structured methodologies. Knowledge of applicable regulatory frameworks, industry standards, and compliance requirements. 4+ years of experience with a demonstrated track record of growth and professional impact. Relevant undergraduate or postgraduate degree aligned with the role's core responsibilities. Superior writing and communication skills with experience preparing executive-level documents. Collaborative, proactive, and able to operate effectively with minimal supervision. 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.