Clinical Operations Manager in Gurgaon, भारत

Clinical Operations Manager responsible for overseeing protocol performance and compliance across assigned clinical trials in India. The role manages country and site budgets, executes regulatory submissions, coordinates with internal and external stakeholders, and ensures adherence to ICH/GCP standards and local regulations.

Responsibilities

• Manage country and site budgets, develop clinical trial research agreements, and oversee payment reconciliation
• Execute clinical trial country submissions and approvals, interact with IRB/IEC and regulatory authorities
• Develop local language materials including informed consents and coordinate translations
• Oversee clinical supplies management, filing, archiving, and ensure local regulatory and financial compliance
• Coordinate with internal teams and external vendors to deliver country-specific trial commitments and milestones

Requirements

• 5 years clinical research experience or combined clinical research and finance/business experience
• Bachelor's degree in business, finance, administration, life science, or healthcare-related field
• Expertise in clinical systems, tools, metrics, and local regulatory environment
• Strong budget and contract negotiation skills with understanding of submission and approval processes
• Fluency in local language and English, both written and verbal
• Ability to work independently with minimal oversight and influence stakeholders indirectly