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Clinical Data Manager

covance by labcorp

Delhi, Pune

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3 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 We are on the lookout for a well-rounded Clinical Data Manager to contribute to our operational and strategic priorities. The organisation is committed to nurturing talent and providing a platform for exceptional career growth. Duties and Accountabilities: Ensure audit-readiness of safety documentation in line with GxP and regulatory expectations. Review and analyse PSURs, PBRERs, DSURs, and other aggregate safety reports. Ensure all cases are coded and processed per MedDRA and applicable global standards. Support collection and review of adverse event safety data from clinical and post-market sources. Maintain up-to-date knowledge of ICH E2A-E2F, GCP, and pharmacovigilance regulations. Prepare high-quality clinical and regulatory documents aligned to CTD submission standards. Assist in preparing and submitting regulatory safety reports in compliance with ICH guidelines. Liaise with clinical, medical affairs, and regulatory teams for accurate safety data management. Key Skills and Qualifications: Commitment to professional ethics, confidentiality, and the highest standards of conduct. Sound understanding of organisational dynamics and stakeholder management in complex environments. Advanced competency in analytical tools, reporting platforms, and role-specific technology. Effective presentation skills with the ability to communicate complex ideas with clarity. Leadership experience with a track record of guiding teams, projects, or cross-functional initiatives. 5+ years of experience with demonstrated progression in scope, complexity, and responsibility. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. A competitive compensation structure along with performance incentives and growth opportunities awaits the right candidate.