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Manager, Tmf Operations – Trial Master File & Clinical Documentation Management

Syneos Health
Syneos Health
8+ years
preferred by company
Hyderabad
1 May 11, 2026
Job Description
Job Type: Hybrid Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development

 

Manager, TMF Operations – Trial Master File & Clinical Documentation Management

Company: Syneos Health
Job Title: Manager, TMF Operations
Location: Hyderabad, India
Work Model: Hybrid
Job ID: 25107714
Department: Clinical Solutions / TMF Operations


About the Role

Syneos Health is hiring a Manager, TMF Operations for its Clinical Solutions team in Hyderabad. This hybrid opportunity is ideal for professionals experienced in Trial Master File (TMF) Management, eTMF Operations, Clinical Documentation, Regulatory Records Management, and Clinical Operations Leadership.

The selected candidate will lead TMF Operations teams, oversee eTMF compliance activities, manage onboarding and mentoring initiatives, support audits and inspections, and ensure high-quality TMF management across global clinical studies.

This role is best suited for candidates with strong expertise in eTMF systems, TMF compliance, stakeholder management, and team leadership.


Key Responsibilities

TMF Operations & Clinical Documentation Management

  • Manage Trial Master File (TMF) Operations teams including:
    • TMF Document Assistants
    • TMF Document Specialists
    • TMF Compliance Specialists
    • TMF Analysts
    • TMF Leads
  • Oversee study assignments and workload management for TMF staff
  • Ensure compliance with TMF quality standards and operational KPIs
  • Monitor TMF workflows and maintain inspection readiness

Leadership, Training & Team Management

  • Lead:
    • New hire onboarding
    • Staff training
    • Mentoring initiatives
    • Performance improvement activities
  • Conduct:
    • Performance appraisals
    • Employee counseling
    • Professional development discussions
  • Participate in interviewing and selection processes
  • Guide junior team members and improve operational efficiency

Audit, Inspection & Compliance Activities

  • Prepare teams and documentation for:
    • Internal audits
    • Sponsor audits
    • Regulatory inspections
  • Ensure ongoing TMF inspection readiness
  • Maintain compliance with:
    • SOPs
    • Work Instructions (WIs)
    • Regulatory documentation standards
  • Support process improvement and compliance initiatives

Stakeholder & Vendor Management

  • Collaborate with:
    • Clinical project teams
    • Clients
    • Vendors
    • Cross-functional stakeholders
  • Act as Subject Matter Expert (SME) for TMF-related activities
  • Coordinate with staffing vendors to manage temporary and flexible workforce requirements

Training & Process Improvement

  • Design and deliver TMF training sessions through:
    • Teleconference
    • Video conference
    • In-person sessions
  • Participate in departmental and business improvement initiatives
  • Ensure staff training compliance and utilization targets are achieved

Document & System Management

  • Manage access to Document Control Rooms according to SOPs
  • Maintain physical and electronic document management systems
  • Work with:
    • Electronic Document Management Systems (eDMS)
    • Web-based clinical systems
    • Microsoft Office applications

Educational Qualification

Candidates should possess a graduate degree in one of the following areas:

  • B.Sc / M.Sc
  • B.Pharm / M.Pharm
  • Biotechnology
  • BDS
  • Life Sciences or related healthcare disciplines

Required Experience

Mandatory Experience

  • Minimum 8 years of eTMF experience
  • At least 3 years in a senior leadership or people management role

Preferred Experience Areas

  • TMF Operations
  • Clinical Documentation Management
  • Regulatory Records Management
  • Clinical Operations
  • Team onboarding, mentoring, and performance management