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Clinical Data Manager

Syngene International

Mumbai, Bangalore

·

2 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 looking for a strategic and detail-oriented Clinical Data Manager to deliver excellence across key functions. The organisation is committed to nurturing talent and providing a platform for exceptional career growth. Scope of Responsibilities: Ensure audit-readiness of safety documentation in line with GxP and regulatory expectations. Maintain up-to-date knowledge of ICH E2A-E2F, GCP, and pharmacovigilance regulations. Coordinate with CROs and licensing partners to fulfil pharmacovigilance obligations. Liaise with clinical, medical affairs, and regulatory teams for accurate safety data management. Support collection and review of adverse event safety data from clinical and post-market sources. Ensure all cases are coded and processed per MedDRA and applicable global standards. Contribute to risk management plans, SOPs, and signal detection and evaluation processes. Participate in regulatory inspections, health authority meetings, and internal audits. Competencies and Qualifications: Detail-oriented mindset with the ability to synthesise and present complex information clearly. Bachelor's degree in a relevant discipline; master's degree or professional certification is preferred. Ability to work both independently and in a team-oriented, collaborative environment. Strong interpersonal and stakeholder management skills with a client-service orientation. Proficiency in relevant software and digital tools specific to the functional area. Commitment to ongoing professional learning and industry knowledge enhancement. 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.