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Clinical Data Manager

HCLTechnologiesLtd

Delhi, Hyderabad

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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 looking for a strategic and detail-oriented Clinical Data Manager to deliver excellence across key functions. The incumbent will operate in a structured yet agile environment that prioritises quality and professional growth. Duties and Accountabilities: Support collection and review of adverse event safety data from clinical and post-market sources. Participate in regulatory inspections, health authority meetings, and internal audits. Ensure all cases are coded and processed per MedDRA and applicable global standards. Review and analyse PSURs, PBRERs, DSURs, and other aggregate safety reports. Conduct structured literature reviews and contribute to scientific summaries and labelling. Ensure audit-readiness of safety documentation in line with GxP and regulatory expectations. Contribute to risk management plans, SOPs, and signal detection and evaluation processes. Maintain up-to-date knowledge of ICH E2A-E2F, GCP, and pharmacovigilance regulations. Key Skills and Qualifications: Leadership experience with a track record of guiding teams, projects, or cross-functional initiatives. Advanced competency in analytical tools, reporting platforms, and role-specific technology. Commitment to professional ethics, confidentiality, and the highest standards of conduct. Critical and strategic thinking skills with the ability to translate insights into clear actions. Recognised qualification in the relevant professional field at the undergraduate or graduate level. Sound understanding of organisational dynamics and stakeholder management in complex environments. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. This is an outstanding opportunity for a motivated professional to advance their career within a reputable organisation.