TMF Specialist (All Levels) – Clinical Research
Locations: Bangalore | Chennai | Bengaluru, India
Job ID: JR132885
Employment Type: Full-Time
Work Model: Hybrid / Office-Based
Function: Regulatory Document Management (TMF)
Business Unit: ICON Full Service & Corporate Support
About ICON plc
ICON plc is a world-leading healthcare intelligence and clinical research organization supporting pharmaceutical, biotechnology, and medical device companies globally. Driven by innovation, integrity, and collaboration, ICON partners with clients to advance clinical development and improve patient outcomes worldwide.
At ICON, people are at the heart of everything we do. Our inclusive culture, guided by accountability, collaboration, partnership, and integrity, enables us to deliver excellence at every stage of drug development.
Role Overview
ICON is hiring TMF Specialists (All Levels) to support Trial Master File (TMF) and regulatory document management activities across global clinical studies. This role offers an excellent opportunity to work in a fast-paced clinical research environment, contributing to document quality, inspection readiness, and regulatory compliance across multiple studies.
The position is suitable for professionals ranging from entry-level to senior TMF experts, depending on experience.
Key Responsibilities
Process and manage clinical study documents in accordance with study-specific requirements, client expectations, ICON SOPs/WPs, and applicable regulatory guidelines.
Perform document receipt, review, scanning, indexing, filing, quality control, reconciliation, and archiving activities.
Maintain TMF completeness, accuracy, and inspection readiness throughout the study lifecycle.
Collaborate closely with study teams, TMF colleagues, and cross-functional stakeholders to meet project timelines and quality standards.
Support preparation of TMF status reports and provide documentation metrics to management as required.
Participate in internal, client, and regulatory audits and support document retrieval and archiving activities.
Provide requested study documentation to ICON and client personnel in a timely manner.
Escalate quality, training, or timeline risks to TMF management proactively.
Participate in role-specific and study-specific training programs.
Support special projects and additional TMF-related responsibilities as assigned.
Required Qualifications & Experience
Experience:
1 to 15 years of Trial Master File (TMF) experience, depending on level, within a CRO, pharmaceutical, biotechnology, or clinical research environment.
Education:
Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, or a related discipline preferred.
Technical Skills:
Strong knowledge of clinical trial documentation, TMF structures, and regulatory requirements (ICH-GCP).
Hands-on experience with electronic TMF (eTMF) systems is highly desirable.
Soft Skills:
Strong written and verbal communication skills.
Excellent attention to detail and organizational abilities.
Ability to collaborate effectively with global study teams, clients, and management.
Why Join ICON
Opportunity to work with a global leader in clinical research on international studies.
Clear career progression pathways across TMF, Regulatory Affairs, and Clinical Operations.
Competitive compensation aligned with market benchmarks.
Comprehensive benefits including health insurance, paid time off, life assurance, and retirement planning.
Global Employee Assistance Program (LifeWorks) providing 24/7 well-being support.
Flexible, country-specific benefits such as wellness programs, childcare support, gym memberships, and travel subsidies.
Inclusive, performance-driven work culture focused on long-term professional growth.
Diversity, Equity & Inclusion
ICON is an equal opportunity employer committed to providing a workplace free from discrimination and harassment. All qualified applicants will receive equal consideration regardless of race, color, religion, gender, sexual orientation, gender identity, nationality, disability, or veteran status.
Accessibility & Accommodations
ICON provides reasonable accommodations for candidates with medical conditions or disabilities throughout the recruitment and employment process.
Ready to Apply?
If you are passionate about clinical research documentation and regulatory compliance—even if you do not meet every listed requirement—ICON encourages you to apply. You may be a strong fit for this role or other TMF opportunities within ICON’s global organization.
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