$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 position is embedded within a high-functioning team that prizes collaboration, innovation, and quality. Main Accountabilities: Conduct benefit-risk assessments and contribute to clinical development strategy discussions. Manage medical coding using MedDRA and WHO Drug Dictionary for clinical trial data. Maintain trial master files and ensure ongoing audit-readiness and regulatory compliance. Plan, monitor, and close clinical trials in compliance with GCP and ICH guidelines. Prepare and maintain essential trial documents including protocols, ICFs, and CSRs. Support IND, NDA, MAA, and dossier submissions with high-quality regulatory documentation. Review source data and ensure completeness, accuracy, and regulatory compliance. Develop SAS programs for SDTM/ADaM dataset creation and table, figure, listing generation. Essential Skills and Experience: Knowledge of applicable regulatory frameworks, industry standards, and compliance requirements. Expertise in applying quantitative and qualitative methods to support evidence-based decisions. Relevant undergraduate or postgraduate degree aligned with the role's core responsibilities. Strong project management capabilities with experience in agile or structured methodologies. 4+ years of experience with a demonstrated track record of growth and professional impact. Excellent attention to detail and commitment to producing accurate, high-quality deliverables. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. Applications are reviewed on a rolling basis; suitably qualified individuals are encouraged to apply promptly.