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Clinical Data Manager

Genpact

Delhi, Kolkata

·

4 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 A dynamic organisation seeks an experienced Clinical Data Manager to take on a multifaceted and impactful role. This is an excellent opportunity for professionals who value structured career advancement and meaningful impact. Main Accountabilities: 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. Conduct benefit-risk assessments and contribute to clinical development strategy discussions. Review source data and ensure completeness, accuracy, and regulatory compliance. Develop SOPs, work instructions, and training materials for clinical operations teams. Maintain trial master files and ensure ongoing audit-readiness and regulatory compliance. Provide clinical site training on data collection standards and regulatory requirements. Support IND, NDA, MAA, and dossier submissions with high-quality regulatory documentation. Essential Skills and Experience: Superior writing and communication skills with experience preparing executive-level documents. Collaborative, proactive, and able to operate effectively with minimal supervision. Strong project management capabilities with experience in agile or structured methodologies. Relevant undergraduate or postgraduate degree aligned with the role's core responsibilities. 4+ years of experience with a demonstrated track record of growth and professional impact. Knowledge of applicable regulatory frameworks, industry standards, and compliance requirements. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. We look forward to welcoming a driven professional who shares our commitment to excellence and sustained impact.