Manager EDC Administration in India at Jobgether

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Manager EDC Administration in India.

This role is responsible for leading and scaling EDC administration operations across a global clinical trial environment, ensuring robust, compliant, and efficient management of the Medidata Rave platform. You will oversee user access, system configuration, and environment governance while driving operational excellence and continuous improvement. The position plays a key role in maintaining regulatory compliance and enabling smooth clinical study execution across multiple functions. You will lead a team of EDC administration professionals, ensuring high-quality delivery and strong alignment with cross-functional stakeholders. Working in a highly regulated and fast-paced environment, you will contribute to inspection readiness and system reliability at scale. This is a leadership role combining technical depth, process governance, and people management within global clinical operations.

You will lead end-to-end EDC administration activities while ensuring compliance, scalability, and operational efficiency across clinical systems.

• Lead and develop a team of EDC Administration professionals, including coaching, performance management, and capability building to ensure high-quality delivery.
• Manage Medidata Rave environments, including user provisioning, role-based access control, system configuration, and deactivation processes.
• Ensure governance, compliance, and regulatory alignment with frameworks such as 21 CFR Part 11 and ICH-GCP.
• Coordinate with cross-functional teams including database developers and data managers for study setup, go-live readiness, and ongoing support.
• Monitor KPIs, operational metrics, and system performance to identify improvement opportunities and enhance delivery efficiency.
• Drive SOP creation, documentation updates, and continuous improvement initiatives across EDC administration processes.
• Support inspection readiness activities and ensure consistent adherence to quality standards across global studies.

The ideal candidate brings strong experience in clinical systems administration, team leadership, and regulated environment operations, with a deep understanding of EDC platforms.

• Bachelor’s degree in life sciences, mathematics, information systems, or a related field.
• 7+ years of experience in the pharmaceutical, biotechnology, or healthcare industry.
• 4+ years of hands-on experience in EDC or clinical systems administration, ideally with Medidata Rave.
• Proven experience leading teams in a matrix or global environment, with strong people management capability.
• Solid understanding of clinical data management workflows, system governance, and operational controls.
• Knowledge of regulatory standards such as 21 CFR Part 11 and ICH-GCP.
• Strong problem-solving, stakeholder management, and communication skills with the ability to influence across functions.

• Competitive compensation aligned with experience and industry benchmarks
• Health and wellness coverage (medical, dental, vision, and related benefits where applicable)
• Opportunities for career growth in global clinical operations and systems leadership
• Exposure to large-scale clinical trial environments and advanced EDC technologies
• Structured learning and development programs
• Collaborative, cross-functional work environment within regulated global operations
• Additional location-based benefits as per company policy