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Clinical Data Manager

Accenture

Pune, Bangalore

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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 position offers the opportunity to work with a diverse, cross-functional team in a results-oriented culture. Main Accountabilities: Manage medical coding using MedDRA and WHO Drug Dictionary for clinical trial data. Support IND, NDA, MAA, and dossier submissions with high-quality regulatory documentation. Monitor safety signals and liaise with pharmacovigilance teams for adverse event management. Track milestones and coordinate with sites, CROs, and sponsors for on-time delivery. Prepare and maintain essential trial documents including protocols, ICFs, and CSRs. Develop SOPs, work instructions, and training materials for clinical operations teams. Plan, monitor, and close clinical trials in compliance with GCP and ICH guidelines. Review source data and ensure completeness, accuracy, and regulatory compliance. 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. Excellent attention to detail and commitment to producing accurate, high-quality deliverables. Knowledge of applicable regulatory frameworks, industry standards, and compliance requirements. Strong project management capabilities with experience in agile or structured methodologies. Relevant undergraduate or postgraduate degree aligned with the role's core responsibilities. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. Candidates who meet the above requirements are encouraged to submit their detailed CV at the earliest opportunity.