$5,00,000 Per Year
$18,00,000 Per Year
Position: Clinical Data Manager Our organisation invites applications from accomplished professionals for the role of Clinical Data Manager. This position is embedded within a high-functioning team that prizes collaboration, innovation, and quality. Role Responsibilities: Plan, monitor, and close clinical trials in compliance with GCP and ICH guidelines. Monitor safety signals and liaise with pharmacovigilance teams for adverse event management. Develop SOPs, work instructions, and training materials for clinical operations teams. Provide clinical site training on data collection standards and regulatory requirements. Track milestones and coordinate with sites, CROs, and sponsors for on-time delivery. Prepare and maintain essential trial documents including protocols, ICFs, and CSRs. Support IND, NDA, MAA, and dossier submissions with high-quality regulatory documentation. Maintain trial master files and ensure ongoing audit-readiness and regulatory compliance. Education and Experience Requirements: Minimum 35 years of progressive professional experience in a comparable role. Proven ability to manage competing priorities in a deadline-driven, dynamic environment. Experience collaborating within cross-functional teams and matrix organisational structures. A bachelor's degree or higher in a relevant field; postgraduate qualifications are an added advantage. Excellent verbal and written communication skills; fluency in English is essential. Strong analytical and problem-solving skills with the ability to navigate complex challenges. 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.