Clinical Operations Manager

About the role

The Clinical Operations Manager is responsible for the performance and compliance of assigned clinical trial protocols in India, ensuring adherence to ICH/GCP, local regulations, and internal quality standards.

Key responsibilities

• Own country and site budgets, develop and negotiate Clinical Trial Research Agreements, and manage financial forecasting and payment reconciliation.
• Execute and oversee clinical trial submissions and approvals, develop local language informed consents, and interact with IRB/IEC and regulatory authorities.
• Manage country deliverables, timelines, and quality compliance, and coordinate with internal and external stakeholders to meet protocol milestones.
• Oversee local regulatory and financial compliance, supply chain logistics, and documentation archiving.

Required profile

• Minimum 5 years of experience in clinical research, with strong knowledge of local regulatory environments and budget/contract negotiations.
• Ability to influence investigators, vendors, and internal teams independently and make decisions with limited oversight.
• Proven problem‑solving skills, high accountability, and ability to work in a remote/virtual environment.

Required skills

• Clinical Trial Management
• Clinical Trial Planning
• Clinical Trial Monitoring
• Clinical Trial Documentation
• Clinical Trial Compliance
• ICH GCP Guidelines
• Regulatory Compliance
• Budget negotiation
• Financial forecasting
• Contract negotiation