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Manager – Tmf Operations

Syneos Health
Syneos Health
8+ years
Not Disclosed
Hyderabad
1 May 8, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Manager – TMF Operations
Location: Hyderabad (Hybrid)
Company: Syneos Health
Job ID: 25107714
Job Type: Full-Time
Industry: Clinical Research / Trial Master File (TMF) Operations / Life Sciences


About the Company

Syneos Health is a globally recognized integrated life sciences organization dedicated to accelerating customer success across the drug development and commercialization lifecycle. The company partners with pharmaceutical, biotechnology, and healthcare innovators to streamline clinical development, regulatory processes, and commercialization strategies worldwide.

With over 25,000 professionals globally, Syneos Health combines scientific expertise, operational excellence, and innovative clinical solutions to support groundbreaking healthcare advancements and patient-focused outcomes.


Job Overview

Syneos Health is hiring an experienced and detail-oriented professional for the position of Manager – TMF Operations. The selected candidate will oversee Trial Master File (TMF) operations, staff management, compliance activities, quality standards, and process improvement initiatives within the Clinical Solutions division.

This role is ideal for professionals with extensive experience in eTMF management, regulatory documentation, team leadership, and clinical operations within pharmaceutical, CRO, or healthcare environments.


Key Responsibilities

  • Manage and supervise TMF Operations teams, including:
    • TMF Document Assistants
    • TMF Document Specialists
    • TMF Compliance Specialists
    • TMF Analysts
    • TMF Leads
  • Oversee study assignments, workflow transitions, and operational resource allocation
  • Conduct performance management, employee mentoring, onboarding, and professional development activities
  • Participate in recruitment, interviewing, and staff selection processes
  • Ensure compliance with TMF quality standards, SOPs, regulatory guidelines, and departmental KPIs
  • Monitor staff productivity, training compliance, utilization, and operational efficiency
  • Support and participate in audits, inspections, and TMF readiness activities
  • Design and deliver TMF-related training sessions through virtual and in-person formats
  • Collaborate with project teams, sponsors, vendors, and cross-functional stakeholders
  • Lead continuous improvement initiatives within TMF Operations and Clinical Solutions
  • Manage temporary staffing coordination and vendor interactions when required
  • Oversee access control and maintenance of document control environments
  • Maintain compliance with electronic document management and regulatory systems
  • Perform additional operational and leadership responsibilities as assigned

Required Qualifications

  • Graduate degree in:
    • Life Sciences
    • Biotechnology
    • Pharmacy
    • Medical or Healthcare-related disciplines

Accepted qualifications include:

  • B.Sc.
  • M.Sc.
  • B.Pharm
  • M.Pharm
  • BDS
  • Biotechnology-related degrees

Experience Requirements

  • Minimum 8 years of mandatory eTMF experience
  • At least 3 years of experience in senior leadership or team management roles
  • Experience managing:
    • New hire onboarding
    • Team mentoring and training
    • Performance improvement initiatives
    • Stakeholder and client communication
  • Freshers are not eligible for this role