$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. Primary Duties and Responsibilities: Monitor safety signals and liaise with pharmacovigilance teams for adverse event management. Develop SAS programs for SDTM/ADaM dataset creation and table, figure, listing generation. Provide clinical site training on data collection standards and regulatory requirements. Manage medical coding using MedDRA and WHO Drug Dictionary for clinical trial data. Support IND, NDA, MAA, and dossier submissions with high-quality regulatory documentation. Maintain trial master files and ensure ongoing audit-readiness and regulatory compliance. Conduct benefit-risk assessments and contribute to clinical development strategy discussions. Develop SOPs, work instructions, and training materials for clinical operations teams. Required Qualifications: At least 24 years of hands-on experience in a comparable professional setting. Ability to work both independently and in a team-oriented, collaborative environment. Strong interpersonal and stakeholder management skills with a client-service orientation. Commitment to ongoing professional learning and industry knowledge enhancement. Bachelor's degree in a relevant discipline; master's degree or professional certification is preferred. Proficiency in relevant software and digital tools specific to the functional area. 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.