Clinical Research Coordinator II (Regulatory Oversight) - Population Health Science & Policy
MaxHealthcare
Mumbai, Pune
·3 w
·Full time
·Healthcare
$3,00,000 Per Year
$7,00,000 Per Year
Position: Clinical Research Coordinator II (Regulatory Oversight) - Population Health Science & Policy An exciting career opportunity exists for a motivated Clinical Research Coordinator II (Regulatory Oversight) - Population Health Science & Policy to advance their professional journey. This position is embedded within a high-functioning team that prizes collaboration, innovation, and quality. Primary Duties and Responsibilities: Manage medical coding using MedDRA and WHO Drug Dictionary for clinical trial data. 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. Track milestones and coordinate with sites, CROs, and sponsors for on-time delivery. Monitor safety signals and liaise with pharmacovigilance teams for adverse event management. Develop SOPs, work instructions, and training materials for clinical operations teams. Prepare and maintain essential trial documents including protocols, ICFs, and CSRs. Review source data and ensure completeness, accuracy, and regulatory compliance. Required Qualifications: At least 24 years of hands-on experience in a comparable professional setting. Exceptional organisational skills with the ability to handle multiple concurrent responsibilities. Commitment to ongoing professional learning and industry knowledge enhancement. Ability to work both independently and in a team-oriented, collaborative environment. Detail-oriented mindset with the ability to synthesise and present complex information clearly. Strong interpersonal and stakeholder management skills with a client-service orientation. 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.