$4,00,000 Per Year
$12,00,000 Per Year
Position: Manager, Clinical Trial Disclosure Group (CTDG) We are currently recruiting a results-oriented Manager, Clinical Trial Disclosure Group (CTDG) to strengthen our high-performing team. This position offers the opportunity to work with a diverse, cross-functional team in a results-oriented culture. Main Accountabilities: Conduct benefit-risk assessments and contribute to clinical development strategy discussions. Monitor safety signals and liaise with pharmacovigilance teams for adverse event management. Maintain trial master files and ensure ongoing audit-readiness and regulatory compliance. Develop SAS programs for SDTM/ADaM dataset creation and table, figure, listing generation. Prepare and maintain essential trial documents including protocols, ICFs, and CSRs. 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. Review source data and ensure completeness, accuracy, and regulatory compliance. Essential Skills and Experience: Superior writing and communication skills with experience preparing executive-level documents. 4+ years of experience with a demonstrated track record of growth and professional impact. Relevant undergraduate or postgraduate degree aligned with the role's core responsibilities. Collaborative, proactive, and able to operate effectively with minimal supervision. Expertise in applying quantitative and qualitative methods to support evidence-based decisions. Knowledge of applicable regulatory frameworks, industry standards, and compliance requirements. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. Candidates who meet the above requirements are encouraged to submit their detailed CV at the earliest opportunity.