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Clinical Data Manager

clario

Chennai, Hyderabad

·

4 w

·

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 expanding our team and seek a driven Clinical Data Manager who brings expertise, initiative, and professionalism. The candidate will join a globally connected team that prizes diverse perspectives and operational excellence. Key Responsibilities: Review and analyse PSURs, PBRERs, DSURs, and other aggregate safety reports. Prepare high-quality clinical and regulatory documents aligned to CTD submission standards. Support collection and review of adverse event safety data from clinical and post-market sources. Ensure audit-readiness of safety documentation in line with GxP and regulatory expectations. Conduct structured literature reviews and contribute to scientific summaries and labelling. Assist in preparing and submitting regulatory safety reports in compliance with ICH guidelines. Participate in regulatory inspections, health authority meetings, and internal audits. Liaise with clinical, medical affairs, and regulatory teams for accurate safety data management. Qualifications and Requirements: High degree of professionalism, integrity, and alignment with organisational values. Strong analytical and problem-solving skills with the ability to navigate complex challenges. Excellent verbal and written communication skills; fluency in English is essential. Experience collaborating within cross-functional teams and matrix organisational structures. Proven ability to manage competing priorities in a deadline-driven, dynamic environment. Demonstrated proficiency with industry-standard tools, platforms, and methodologies. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. This position represents a unique platform for a high-calibre professional to make a lasting contribution.