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Clinical Data Manager

Quanticate

Bangalore, Hyderabad

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4 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 seek a dedicated and solutions-focused Clinical Data Manager to join our cross-functional, high-performing team. The successful candidate will be part of a collaborative, high-performance environment committed to excellence. Responsibilities Include: 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. Conduct structured literature reviews and contribute to scientific summaries and labelling. 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. Contribute to risk management plans, SOPs, and signal detection and evaluation processes. Prepare high-quality clinical and regulatory documents aligned to CTD submission standards. Review and analyse PSURs, PBRERs, DSURs, and other aggregate safety reports. Skills and Qualifications: 26 years of relevant industry experience with evidence of increasing responsibility. Strong communication, presentation, and interpersonal skills across all organisational levels. Hands-on experience with tools, software, and platforms standard to the profession. A structured, results-driven approach with the ability to meet defined milestones consistently. Demonstrated teamwork skills and the ability to build trust and rapport across functions. Willingness to travel, adapt, and take on additional responsibilities as the business demands. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. We offer a competitive remuneration package commensurate with experience and market standards. Qualified candidates are encouraged to apply.