TMF Specialist I - Clinical Documentation & Trial Master File Operations

Why This Role Matters

Accurate and complete documentation is the backbone of every successful clinical trial. Regulatory authorities require sponsors and CROs to maintain a well-organized Trial Master File (TMF) that demonstrates compliance with Good Clinical Practice (GCP), protocol adherence, and participant safety. Even minor documentation gaps can lead to inspection findings, compliance risks, or delays in regulatory approvals.
The TMF Specialist I plays a foundational role in maintaining documentation quality and ensuring inspection readiness. At ICON plc, this position supports global clinical studies by contributing to document management activities, maintaining organized TMF structures, and ensuring adherence to both client and internal requirements. This role is ideal for professionals looking to strengthen their expertise in clinical documentation while building a long-term career in clinical research operations.

Job Description

The TMF Specialist I is responsible for supporting Trial Master File management activities across assigned projects. This role focuses on gaining familiarity with TMF structures, essential document requirements, document indexing, and compliance processes.
Working closely with cross-functional teams, the TMF Specialist I assists in maintaining accurate and complete documentation within electronic document management systems. The role ensures that documentation activities align with client contracts, regulatory standards, and ICON procedures.
This position requires strong attention to detail, organizational discipline, and a willingness to learn regulatory frameworks and documentation standards within a dynamic clinical research environment.

Key Features of the Role

• Entry-to-mid level opportunity within TMF Operations
• Exposure to global clinical trial documentation processes
• Hands-on experience with electronic document management systems
• Cross-functional collaboration with Clinical Operations teams
• Strong learning and development pathway
• Foundation for career growth into TMF Specialist II, Senior TMF Specialist, or Clinical Operations roles
• Compliance-focused and quality-driven environment

Responsibilities

• Gain familiarity with Trial Master File (TMF) structure and essential document categories.
• Assist in organizing, filing, and maintaining TMF documentation in electronic systems.
• Ensure documents are uploaded, indexed, and classified correctly according to internal SOPs and client requirements.
• Support ongoing document reconciliation and tracking activities.
• Contribute to client services contracts and internal business requirements related to TMF management.
• Verify document completeness and accuracy prior to filing.
• Maintain audit-ready documentation standards under supervision.
• Collaborate with Clinical Trial Managers, CRAs, and Regulatory teams to obtain required documents.
• Follow established workflows for document review and approval processes.
• Support quality checks to ensure compliance with ICH-GCP guidelines.
• Assist in responding to internal queries related to document location and filing status.
• Contribute to continuous improvement initiatives within TMF processes.

Required Qualifications

• Understanding or willingness to learn Trial Master File documentation standards.
• Basic knowledge of clinical research processes preferred.
• Strong organizational and document management skills.
• High attention to detail and accuracy.
• Ability to work within structured SOP-driven environments.
• Effective communication skills for cross-team collaboration.
• Ability to manage assigned tasks within defined timelines.

Educational Requirements

• Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, Nursing, or a related scientific discipline.
• Additional certification in Clinical Research or Regulatory Affairs is an advantage but not mandatory.

Experience and Skills

• 3+ years of prior experience in clinical research, document management, or related roles preferred.
• Familiarity with electronic document management systems (eTMF systems preferred).
• Basic understanding of ICH-GCP guidelines and regulatory documentation standards.
• Experience supporting cross-functional teams in documentation activities.
• Strong proficiency in Microsoft Office tools.
• Ability to prioritize tasks and manage workload effectively.
• Strong written and verbal communication skills.
• Demonstrated ability to work effectively within a team environment.

Salary Insights

Compensation for the TMF Specialist I role is competitive and aligned with entry-to-mid level clinical documentation positions within global CROs. Salary may vary depending on experience, skillset, and geographic location.

In addition to base salary, employees at ICON plc may receive:
• Health insurance coverage for employees and families
• Retirement savings programs
• Annual leave entitlements
• Life assurance benefits
• Global Employee Assistance Programme (LifeWorks)
• Flexible country-specific optional benefits such as wellness initiatives and lifestyle programs

ICON’s total rewards structure is designed to support professional growth, financial security, and work-life balance.

Company Overview

ICON plc is a globally recognized healthcare intelligence and clinical research organization that partners with pharmaceutical, biotechnology, and medical device companies to accelerate the development of innovative therapies.
Operating across multiple continents, ICON provides comprehensive clinical development services spanning early-phase trials through post-marketing research. The company emphasizes operational excellence, regulatory compliance, and scientific innovation.
ICON fosters a diverse and inclusive workplace culture, committed to equal opportunity employment and accessible work environments. Professional development, collaboration, and continuous learning are central to the organization’s values.

FAQs

1. Is prior TMF experience mandatory?
While prior TMF or document management experience is preferred, candidates with clinical research exposure and strong documentation skills are encouraged to apply.

2. Is this role suitable for freshers?
The role prefers candidates with some prior experience (3+ years), but relevant internships or document management exposure may be considered.

3. Does this role involve regulatory inspections?
The role supports inspection readiness activities but does not independently lead inspections at this level.

4. What growth opportunities are available?
Progression may include TMF Specialist II, Senior TMF Specialist, or broader Clinical Operations roles.

5. Is system experience required?
Familiarity with electronic document management systems is beneficial but can be developed on the job.

Application Tips

• Highlight any TMF, eTMF, or document management experience clearly.
• Demonstrate understanding of GCP and regulatory documentation standards.
• Showcase examples of accuracy and attention to detail in previous roles.
• Mention experience working with cross-functional teams.
• Emphasize organizational skills and ability to meet timelines.
• Quantify experience where possible (number of studies supported, documents handled, etc.).