Manager, Clinical Operations – Clinical Trial Leadership Role
Location: Gurugram, India
Job Type: Full-Time
Company: Syneos Health
Experience Required: 8 to 12 years
Job Overview
The Manager, Clinical Operations is a leadership role responsible for overseeing end-to-end clinical trial operations, including site selection, regulatory submissions, site activation, monitoring, and study close-out. This position provides direct supervision to Clinical Operations teams, ensuring delivery of high-quality clinical research in compliance with ICH-GCP guidelines and global regulatory standards. The role requires strong people management, operational oversight, and strategic planning capabilities to support successful clinical trial execution and client satisfaction.
Key Responsibilities
Lead and manage Clinical Operations staff, including hiring, performance management, training, and career development, ensuring high team performance and engagement. Oversee site selection, regulatory and ethics submissions, site contracts, site activation, and monitoring activities across assigned clinical studies. Ensure projects are adequately resourced by managing workload distribution and identifying staffing needs proactively. Provide operational leadership by monitoring study progress, ensuring metric compliance, and implementing corrective and contingency plans where necessary. Ensure adherence to Standard Operating Procedures (SOPs), Work Instructions, and global regulatory requirements including ICH-GCP guidelines. Collaborate with cross-functional teams and stakeholders to ensure timely delivery of clinical trial milestones and client expectations. Support business development initiatives by contributing as a subject matter expert in Clinical Operations during client presentations and proposals. Conduct performance reviews, staff mentoring, and training programs to enhance team capabilities and address performance gaps. Monitor budgets, timelines, and risks, ensuring optimal project delivery and financial oversight. Drive continuous process improvements and quality initiatives at the business unit level. Organize and lead team meetings, ensuring effective communication, issue resolution, and follow-up on action items. Oversee audit readiness and quality control processes to ensure compliance with internal and external standards.
Education and Qualifications
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related discipline is required. Advanced degrees or equivalent experience in clinical research or healthcare management are preferred.
Experience Requirements
A minimum of 8 to 12 years of experience in clinical research, including significant experience in clinical operations within a CRO, pharmaceutical, or biotechnology organization. Proven leadership experience managing teams of 10–15 or more direct reports is essential. Strong experience in regulatory and study start-up processes is required.
Key Skills and Competencies
Comprehensive knowledge of clinical trial processes, ICH-GCP guidelines, and global regulatory requirements. Strong leadership and team management skills with the ability to mentor and develop high-performing teams. Excellent communication, stakeholder management, and presentation skills. Strong analytical, organizational, and problem-solving abilities to manage complex clinical programs. Proficiency in project management, budgeting, and forecasting within clinical operations. Ability to work in a fast-paced, dynamic environment while managing multiple priorities effectively. Familiarity with clinical systems, dashboards, and reporting tools.
Work Environment
This role is primarily office-based with flexibility depending on project requirements. Travel of up to 25 percent may be required for site visits, client meetings, and audits.
Why Join Syneos Health
Syneos Health offers a dynamic and collaborative environment focused on accelerating clinical development and improving patient outcomes. With a global presence and a strong emphasis on innovation, professional development, and diversity, this role provides an opportunity to lead impactful clinical programs and contribute to the advancement of life-changing therapies.
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