Clinical Data Management - Trial Manager
Genpact
Bangalore, Hyderabad
·4 w
·Full time
·Healthcare
$5,00,000 Per Year
$18,00,000 Per Year
Position: Clinical Data Management - Trial Manager Join our forward-thinking team as a Clinical Data Management - Trial Manager and play a pivotal role in our continued success. This role provides exposure to strategic initiatives and direct collaboration with senior leadership. Role Responsibilities: Prepare and maintain essential trial documents including protocols, ICFs, and CSRs. Track milestones and coordinate with sites, CROs, and sponsors for on-time delivery. Review source data and ensure completeness, accuracy, and regulatory compliance. Develop SOPs, work instructions, and training materials for clinical operations teams. Conduct benefit-risk assessments and contribute to clinical development strategy discussions. Support IND, NDA, MAA, and dossier submissions with high-quality regulatory documentation. Plan, monitor, and close clinical trials in compliance with GCP and ICH guidelines. Develop SAS programs for SDTM/ADaM dataset creation and table, figure, listing generation. Education and Experience Requirements: 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. Proven ability to manage competing priorities in a deadline-driven, dynamic environment. Excellent verbal and written communication skills; fluency in English is essential. Demonstrated proficiency with industry-standard tools, platforms, and methodologies. High degree of professionalism, integrity, and alignment with organisational values. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. This role offers exceptional career growth, a collaborative culture, and a compensation structure aligned to market benchmarks.