Clinical Study Manager – Clinical Operations
Division: Discovery Services
Department: Translational and Clinical Research
Location: India
Employment Type: Full-time
Date Posted: January 14, 2026
About Syngene
Syngene is an innovation-driven Contract Research, Development, and Manufacturing Organization (CRDMO) offering integrated scientific services from early discovery through commercial supply. With a strong global presence, Syngene partners with leading pharmaceutical, biotechnology, and life sciences organizations to accelerate research outcomes while upholding the highest standards of quality, compliance, and data integrity.
At Syngene, safety is a core value and is treated with equal importance as business performance. Every employee shares responsibility for maintaining a safe, compliant, and ethical working environment in accordance with established policies, procedures, and SOPs.
Role Overview
Syngene is seeking an experienced Clinical Study Manager to lead and manage clinical studies within its Translational and Clinical Research function. This role is responsible for end-to-end clinical study management, cross-functional coordination, sponsor communication, risk mitigation, and team leadership to ensure timely delivery of high-quality clinical trial outcomes.
The Clinical Study Manager serves as the primary point of contact for sponsors and internal stakeholders, driving operational excellence, regulatory compliance, and continuous improvement across clinical trial execution.
Key Responsibilities
Clinical Study & Project Management
Lead and coordinate Clinical Trial Management teams and cross-functional project groups to achieve study milestones
Develop and maintain comprehensive Project Management and Study Management Plans
Serve as the primary liaison with sponsors, ensuring consistent communication, reporting, and issue resolution
Ensure standardized use of clinical study tools, training materials, and operational processes
Track team performance against contractual obligations, timelines, and quality benchmarks
Risk, Quality & Compliance Oversight
Identify, assess, and manage study risks, contingencies, and operational challenges
Review clinical communications, monitoring reports, data flow metrics, and audit findings to detect quality issues
Implement corrective and preventive action plans and escalate findings as required
Ensure protocol adherence, SOP compliance, and regulatory alignment across all study sites
Coordinate with Quality Assurance teams to support closure of internal and external audit findings
Team Leadership & Development
Provide mentoring, training, and performance oversight to Clinical Research Associates and project staff
Conduct co-monitoring and accompanied site visits to ensure clinical team effectiveness
Support workload planning, performance reviews, and professional development initiatives
Review and validate timesheets and provide structured feedback to reporting managers
Operational & Strategic Support
Conduct and support site feasibility assessments for awarded studies
Participate in proposal development, budgeting, and resource planning for new projects
Prepare and present study updates at internal and external meetings
Contribute to the development and continuous improvement of departmental SOPs and work practices
Safety, Quality & Organizational Expectations
Ensure strict adherence to Syngene’s Environment, Health, and Safety (EHS) standards
Promote a culture of safety, quality, integrity, and operational discipline
Complete all mandatory trainings related to data integrity, safety, and compliance
Govern and review safety metrics and hold teams accountable for safety performance
Required Qualifications & Experience
Education:
Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Clinical Research, or a related discipline
Experience Required:
7–10 years of experience in clinical operations or clinical trial management
Proven experience managing global or regional clinical studies within a CRO, pharmaceutical, or biotech environment
Prior hands-on experience leading cross-functional teams and sponsor interactions
Key Skills & Competencies
Strong clinical trial management and project leadership skills
In-depth knowledge of ICH-GCP, regulatory requirements, and clinical research SOPs
Excellent communication, stakeholder management, and problem-solving abilities
Demonstrated ability to manage complex studies, timelines, and budgets
High level of professionalism, integrity, and operational accountability
Syngene Core Values
All employees are expected to consistently demonstrate alignment with Syngene’s core values:
Excellence
Integrity
Professionalism
Equal Opportunity Employer
Syngene is an equal opportunity employer and is committed to fostering an inclusive workplace. Employment decisions are made without regard to age, race, gender, disability, religion, sexual orientation, marital status, or any other protected characteristic. Reasonable accommodations are provided to qualified individuals with disabilities in accordance with applicable laws.
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