$5,00,000 Per Year
$18,00,000 Per Year
Position: Clinical Data Manager A distinguished opportunity awaits a seasoned Clinical Data Manager within our progressive, innovation-led organisation. This role sits within a fast-paced, innovation-driven organisation that values integrity and continuous improvement. Key Deliverables and Responsibilities: Prepare and maintain essential trial documents including protocols, ICFs, and CSRs. Plan, monitor, and close clinical trials in compliance with GCP and ICH guidelines. Track milestones and coordinate with sites, CROs, and sponsors for on-time delivery. Support IND, NDA, MAA, and dossier submissions with high-quality regulatory documentation. Develop SAS programs for SDTM/ADaM dataset creation and table, figure, listing generation. Monitor safety signals and liaise with pharmacovigilance teams for adverse event management. Provide clinical site training on data collection standards and regulatory requirements. Conduct benefit-risk assessments and contribute to clinical development strategy discussions. Professional Requirements: A structured, results-driven approach with the ability to meet defined milestones consistently. Hands-on experience with tools, software, and platforms standard to the profession. Bachelor's or master's degree in a related discipline with strong academic and professional credentials. Willingness to travel, adapt, and take on additional responsibilities as the business demands. 26 years of relevant industry experience with evidence of increasing responsibility. Familiarity with regulatory, compliance, or quality frameworks applicable to the industry. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. The organisation provides a comprehensive benefits package and excellent career advancement opportunities for the right candidate.