Job Title: Clinical Study Manager
Location: India (Bangalore/Karnataka preferred)
Department: Clinical Operations – Translational and Clinical Research
Division: Discovery Services
Employment Type: Full-Time, Permanent
Syngene International Ltd. is an innovation-driven contract research, development, and manufacturing organization (CRDMO) providing end-to-end scientific services across the drug discovery and development lifecycle. From early discovery through commercial supply, Syngene leverages advanced technologies, cross-functional expertise, and regulatory knowledge to deliver high-quality solutions for the global pharmaceutical and biotechnology industries.
At Syngene, safety, quality, and compliance are central to all operations. The organization emphasizes a culture of accountability, environmental, health, and safety (EHS) mindfulness, and operational discipline to ensure safe and efficient processes across all teams.
The Clinical Study Manager (CSM) will oversee clinical trial operations, coordinating cross-functional teams to ensure project milestones, study quality, and regulatory compliance are met. The ideal candidate will have proven leadership experience in clinical operations, strong project management skills, and expertise in monitoring complex clinical trials.
The CSM acts as the primary point of contact for sponsors, leading study teams, ensuring adherence to SOPs, regulatory guidelines, and clinical protocols, while providing mentorship to Clinical Research Associates (CRAs) and site teams.
Lead and coordinate clinical trial management teams to achieve project milestones and manage study issues or obstacles.
Develop and implement Project Management Plans and coordinate with cross-functional teams, sponsors, and vendors.
Serve as primary liaison with sponsors, maintaining communication, reporting schedules, and project documentation.
Ensure consistent use of study tools, training materials, and compliance with SOPs, policies, and regulatory guidelines.
Monitor study performance, identify quality issues, and implement corrective action plans.
Conduct and oversee site feasibility assessments, monitoring visits, and protocol compliance reviews.
Mentor, train, and evaluate Clinical Research Associates (CRAs) and Senior CRAs to ensure high performance and professional development.
Oversee data quality, adherence to protocols, SOPs, and applicable regulations at study sites.
Provide input on project budgets, proposals, and departmental SOPs.
Collaborate with Quality Assurance teams to address and close audit findings, both internal and external.
Act as a reporting manager, managing team performance, development, goal setting, and compliance with organizational policies.
Promote a culture of Excellence, Integrity, and Professionalism within the clinical operations team.
Minimum 7–10 years of experience in clinical operations or clinical trial management within CRO, pharmaceutical, or biotechnology organizations.
Proven experience managing clinical trials, cross-functional teams, and sponsor communications.
Strong knowledge of ICH-GCP guidelines, regulatory compliance, SOP management, and clinical trial processes.
Demonstrated ability in project management, budget oversight, and risk management.
Experience mentoring and leading CRAs and site teams.
Excellent verbal and written communication skills with ability to interact with global stakeholders.
Ability to travel for site visits and sponsor meetings as required.
Advanced problem-solving, analytical, and organizational skills.
Lead complex clinical trials and contribute to translational research projects with global impact.
Opportunity to mentor, develop, and manage high-performing clinical teams.
Exposure to international regulatory environments and cutting-edge clinical research practices.
Work within a safety-driven, high-quality, and compliance-focused environment.
Contribute to the development of departmental SOPs, project management best practices, and continuous improvement initiatives.
Syngene is committed to equal employment opportunities for all qualified individuals. Employment decisions are made without discrimination based on age, race, color, religion, gender, sexual orientation, disability, or any other legally protected characteristic. Reasonable accommodations are provided to qualified individuals with disabilities.
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