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Manager, Tmf Operations (Trial Master File Operations)

Syneos Health
Syneos Health
8+ years
preferred by company
Hyderabad
1 May 13, 2026
Job Description
Job Type: Hybrid Education: M.Pharm/B.Pharm or M.Sc. Skills: gmp knowledge, HSE Knowledge , Logistics and Transportation Management, Master Data, Operational Excellence, Sap Erp, supply chain management, Supply Planning, Warehouse Management, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill

Job Title: Manager, TMF Operations (Trial Master File Operations)

Location: Hyderabad, Telangana, India (Hybrid)
Job Type: Full-Time
Experience Required: 8+ Years (Freshers are not eligible)
Industry: Clinical Research / CRO / Trial Master File Management / Clinical Operations / Pharmaceuticals / Biotechnology / Life Sciences
Department: Clinical Solutions / TMF Operations / Clinical Documentation Management

About the Role
We are seeking an experienced and operationally strong Manager, TMF Operations to lead global Trial Master File (TMF) operations, documentation governance, inspection readiness, team leadership, and process excellence within a clinical research environment. This senior leadership opportunity is ideal for professionals with expertise in eTMF systems, TMF compliance, clinical document management, inspection readiness, operational leadership, and stakeholder management.

The ideal candidate will oversee TMF operations teams, drive document quality and compliance excellence, manage workforce performance, and ensure TMF operational readiness across global clinical studies.

This opportunity is highly suited for experienced clinical documentation leaders seeking growth in CRO clinical operations leadership.

Key Responsibilities

TMF Operations Leadership & Clinical Documentation Governance

  • Lead end-to-end Trial Master File (TMF) operations across assigned global clinical studies and operational programs.
  • Oversee TMF documentation workflows, quality management, compliance standards, and inspection readiness initiatives.
  • Ensure TMF records are complete, accurate, audit-ready, and aligned with clinical trial regulatory requirements.
  • Drive operational excellence across electronic Trial Master File (eTMF) systems and documentation governance processes.

Team Management & People Leadership

  • Manage TMF Operations staff including:
    • TMF Document Assistants
    • TMF Document Specialists
    • TMF Compliance Specialists
    • TMF Analysts
    • TMF Leads
  • Lead hiring, onboarding, performance management, mentoring, employee development, and team capability enhancement.
  • Conduct regular performance reviews, coaching sessions, and career development discussions.
  • Support employee counseling, professional growth planning, and workforce performance optimization.

Training, Mentorship & Capability Development

  • Lead onboarding programs for new hires and ensure smooth operational integration.
  • Design and deliver TMF training programs through virtual, hybrid, and in-person formats.
  • Act as a Subject Matter Expert (SME) for TMF processes, systems, compliance standards, and documentation best practices.
  • Mentor junior team members and improve performance across operational teams.

Quality Compliance & Inspection Readiness

  • Ensure ongoing compliance with TMF quality standards, SOPs, Work Instructions (WIs), and regulatory expectations.
  • Support internal audits, sponsor inspections, regulatory inspections, and TMF readiness assessments.
  • Drive corrective actions, compliance improvements, and documentation quality remediation where required.
  • Maintain continuous inspection readiness across TMF operations.

Operational Performance & KPI Management

  • Monitor operational performance, workforce productivity, quality metrics, utilization targets, and departmental KPIs.
  • Ensure successful achievement of TMF delivery timelines, documentation quality goals, and compliance expectations.
  • Review workforce utilization, timecards, training compliance, expenses, and resource allocation.

Resource Planning & Workflow Management

  • Assign resources across studies, workflows, and operational transitions to ensure smooth execution.
  • Manage shifting business priorities, study transitions, staffing needs, and workflow balancing.
  • Coordinate temporary or flexible staffing support with workforce vendors where applicable.

Stakeholder Management & Cross-Functional Collaboration

  • Collaborate with:
    • Clinical project teams
    • Sponsors / clients
    • Vendors
    • Quality teams
    • Clinical operations leadership
    • Documentation stakeholders
  • Serve as a strategic TMF stakeholder advisor outside the immediate TMF function.
  • Support issue resolution, operational governance, and stakeholder communication effectively.

Process Improvement & Operational Excellence

  • Lead or contribute to business process improvement initiatives, documentation optimization, and operational transformation programs.
  • Identify workflow inefficiencies and implement scalable TMF operational improvements.
  • Support continuous improvement culture across the clinical documentation organization.

Document Control & Physical TMF Oversight

  • Manage document control access, governance, and applicable physical documentation workflows where required.
  • Ensure document control procedures align with SOPs and quality expectations.

Required Qualifications

  • Bachelor’s or Master’s degree in:
    • Life Sciences
    • Pharmacy
    • Biotechnology
    • Biomedical Sciences
    • Clinical Research
    • BDS
    • Related healthcare/scientific disciplines
  • Minimum 8+ years of mandatory eTMF experience in clinical research, CRO, or pharmaceutical environments.
  • Minimum 3+ years in senior leadership roles managing teams, onboarding, mentoring, and performance improvement.
  • Strong expertise in:
    • eTMF systems
    • TMF compliance
    • Trial Master File governance
    • Inspection readiness
    • Clinical documentation quality
    • SOP / WI compliance
  • Proven stakeholder management experience across clients, project teams, and vendor ecosystems.
  • Strong operational leadership, workforce management, quality oversight, and problem-solving capabilities.
  • Excellent communication, training, and leadership skills.