Hybrid Clinical Trial Documentation Job at Syneos Health, Hyderabad
Want to build a Leadership Career in Clinical Trial Documentation and TMF Operations? Syneos Health is hiring for the Manager, TMF Operations role in Hyderabad. This hybrid opportunity at Syneos Health Careers is ideal for experienced life sciences professionals with expertise in electronic Trial Master File (eTMF) management and clinical documentation processes. The selected candidate will lead TMF Operations teams, oversee regulatory documentation workflows, and ensure compliance with quality standards. The Hybrid Clinical Trial Documentation Job in Hyderabad also involves staff mentoring, audit readiness, stakeholder management, and process improvement initiatives. Professionals with strong leadership skills and clinical operations experience can explore significant career growth in this global CRO environment.
About the Company:
Syneos Health is a leading fully integrated life sciences services organization that supports pharmaceutical, biotechnology, and healthcare companies across the drug development and commercialization process. The company partners with global innovators to accelerate clinical research, regulatory processes, and patient-focused healthcare solutions. Syneos Health operates worldwide with expertise in clinical development, medical affairs, and commercialization services.
Job Details;
- Job Role: Manager, TMF Operations
- Location: Hyderabad
- Work Mode: Hybrid
- Job Type: Full-Time
- Department: Clinical Solutions
- Experience Required: Minimum 8 years of eTMF experience
- Application Deadline: 31 May 2026
- Travel Requirement: Up to 25% travel
- Job Requisition ID: 25107714
Key Responsibilities:
- Manage TMF Operations teams, including TMF Specialists, Analysts, Leads, and Compliance staff
- Oversee onboarding, training, mentoring, and performance improvement of junior employees
- Monitor staff performance and conduct performance appraisals
- Assign resources and manage ongoing study workflows and transitions
- Ensure compliance with quality standards and TMF operational KPIs
- Prepare for audits and inspections to maintain TMF readiness
- Deliver TMF training through teleconference, video conference, or in-person sessions
- Coordinate with project teams, clients, vendors, and stakeholders
- Manage document control room access and document workflows
- Support department process improvement initiatives
Educational Requirements for this Job:
- BDS or a related field
- Minimum 8 years of eTMF experience
- At least 3 years of experience in a senior or leadership role
- Experience in clinical or medical environments involving regulatory records
Skills Required:
- Expertise in eTMF operations and regulatory documentation
- Leadership and team management skills
- Knowledge of clinical research regulations and guidelines
- Understanding of medical terminology
- Strong organizational and multitasking abilities
- Stakeholder and client management skills
- Experience in audit and inspection readiness
- Proficiency in Electronic Document Management Systems
- Microsoft Office Suite proficiency
- Excellent verbal and written communication skills
Benefits of the Hybrid Clinical Trial Documentation Job:
- Opportunity to work with a globally recognized CRO organization
- Leadership role in clinical operations and TMF management
- Exposure to global clinical trial documentation systems
- Hybrid work flexibility
- Career development and progression opportunities
- Training in therapeutic and technical areas
- Inclusive and collaborative work culture
- Opportunity to contribute to innovative healthcare and drug development projects
