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Clinical Data Manager

Wipro

Chennai, Mumbai

·

3 w

·

Full time

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Healthcare

Minimum

$5,00,000 Per Year

Maximum

$18,00,000 Per Year

Position: Clinical Data Manager A compelling career opportunity exists for a skilled Clinical Data Manager to drive meaningful impact. The organisation is committed to nurturing talent and providing a platform for exceptional career growth. Scope of Responsibilities: Conduct structured literature reviews and contribute to scientific summaries and labelling. Maintain up-to-date knowledge of ICH E2A-E2F, GCP, and pharmacovigilance regulations. Ensure audit-readiness of safety documentation in line with GxP and regulatory expectations. Coordinate with CROs and licensing partners to fulfil pharmacovigilance obligations. Prepare high-quality clinical and regulatory documents aligned to CTD submission standards. Liaise with clinical, medical affairs, and regulatory teams for accurate safety data management. Participate in regulatory inspections, health authority meetings, and internal audits. Support collection and review of adverse event safety data from clinical and post-market sources. Competencies and Qualifications: Exceptional organisational skills with the ability to handle multiple concurrent responsibilities. Proficiency in relevant software and digital tools specific to the functional area. Strong interpersonal and stakeholder management skills with a client-service orientation. Commitment to ongoing professional learning and industry knowledge enhancement. Detail-oriented mindset with the ability to synthesise and present complex information clearly. Ability to work both independently and in a team-oriented, collaborative environment. 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.