Manager, TMF Operations (Job ID: 25107714)
Company: Syneos Health
Location: IND – Hyderabad (Hybrid)
Job Type: Full-time, Managerial Role
Experience Level: 8+ years (including 3+ years in leadership roles)
Role Summary
The Manager, TMF Operations is responsible for leading Trial Master File (TMF) operations teams, ensuring inspection readiness, regulatory compliance, and high-quality document management across clinical studies. The role includes people management, process oversight, training, and operational excellence within electronic TMF (eTMF) environments.
Key Responsibilities
Team & People Management
Manage TMF operations staff including:
TMF Document Assistants
TMF Document Specialists
TMF Compliance Specialists
TMF Analysts / TMF Leads
Oversee study assignments and workload distribution
Conduct performance reviews, appraisals, and employee counseling
Lead recruitment, onboarding, and training of new hires
Support professional development and mentoring of team members
Operational Oversight
Ensure delivery of TMF operational KPIs and quality standards
Monitor staff performance, utilization, and compliance
Approve timecards, expenses, and training completion
Manage transitions across studies, workflows, and processes
Quality & Compliance
Ensure TMF compliance with SOPs, WIs, and regulatory requirements
Prepare and support audits and regulatory inspections
Maintain inspection readiness of TMF systems and documentation
Control access to Document Control Room as per SOPs
Process Improvement & Leadership
Lead or support departmental process improvement initiatives
Contribute to business unit-level operational enhancements
Deliver or design TMF training programs (virtual/in-person)
Coordinate with staffing vendors for temporary workforce needs
Stakeholder Management
Collaborate with internal teams, vendors, and project stakeholders
Provide guidance on TMF policies, technical issues, and priorities
Required Qualifications
Education
Graduate degree in Life Sciences or related field:
BSc / MSc
B.Pharm / M.Pharm
BDS
Biotechnology or equivalent
Experience
8+ years in clinical/medical/regulatory documentation environment
Strong experience in eTMF operations
Minimum 3 years in a leadership or people management role
Experience with regulatory records and clinical documentation preferred
Skills & Competencies
Strong knowledge of regulatory guidelines and clinical documentation standards
Leadership and team management capabilities
Excellent communication (verbal and written)
Strong organizational and multitasking ability
Experience with Electronic Document Management Systems (EDMS/eTMF)
Proficiency in:
Microsoft Office (Word, Excel, PowerPoint)
Email and web-based systems
Ability to work in fast-paced, deadline-driven environments
Strong attention to quality, compliance, and detail
Work Environment
Hybrid work model (Hyderabad, India)
May require up to 25% travel
Dynamic, multi-study clinical operations environment
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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