TMF Specialist Job at ICON all levels in Bangalore and Chennai for clinical research professionals with Trial Master File experience.
TMF Specialist (All Levels) Job – ICON
Job ID: JR132885
Company: ICON plc
Locations: Bangalore & Chennai, India
Work Model: Hybrid / Office-Based
Employment Type: Full-Time
Experience Required: 1–15 Years
Industry: Clinical Research / Regulatory Document Management
Application Mode: Online Application
ICON plc, a world-leading healthcare intelligence and clinical research organization, is hiring TMF Specialists (All Levels) to join its Regulatory Document Management team in India. This role offers an excellent opportunity for professionals with Trial Master File (TMF) experience to work in a global CRO environment supporting clinical studies across multiple therapeutic areas. TMF Specialist Job at ICON
About the Company
ICON plc is a global Contract Research Organization providing outsourced development services to the pharmaceutical, biotechnology, and medical device industries. ICON is known for its strong culture built on Accountability, Collaboration, Partnership, and Integrity, with a clear mission to advance and improve patients’ lives through high-quality clinical research. TMF Specialist Job at ICON
Job Details
- Job Title: TMF Specialist (All Levels)
- Company Name: ICON plc
- Job ID: JR132885
- Employment Type: Full-Time
- Work Location: Bangalore & Chennai, India
- Work Mode: Hybrid / Office-Based
- Experience Level: 1–15 Years
- Functional Area: Regulatory Document Management / TMF
Job Description
As a TMF Specialist, you will support document management activities for clinical studies in compliance with ICON SOPs, study-specific processes, and regulatory requirements. The role involves managing Trial Master Files, supporting audits, coordinating with study teams, and ensuring document quality, completeness, and inspection readiness. TMF Specialist Job at ICON
Key Responsibilities
- Process study documents according to client, study, and regulatory requirements
- Maintain study files as per ICON SOPs, working practices, and applicable regulations
- Perform document receipt, review, scanning, indexing, quality control, filing, and archiving
- Liaise with study teams, TMF colleagues, and cross-functional stakeholders
- Support departmental and client projects within defined timelines
- Provide data for client and internal TMF status reports
- Support internal and client audits, inspections, and document archiving activities
- Provide requested study documents to ICON or client personnel
- Participate in TMF-related training and compliance activities
- Escalate quality, training, or timeline issues to the TMF Manager
- Handle special projects and additional duties as assigned
TMF Specialist Job at ICON
Skills / Qualifications
Required Qualifications
- 1–15 years of experience in Trial Master File (TMF) or clinical document management
- Strong knowledge of clinical study documentation
- Bachelor’s degree in Life Sciences (preferred)
- Excellent oral, written, and interpersonal communication skills
- Ability to work effectively with study teams, clients, and management
TMF Specialist Job at ICON
Benefits / Perks
- Competitive salary packages benchmarked against industry standards
- Annual performance-based bonuses
- Comprehensive health insurance for employees and families
- Paid time off and flexible leave policies
- Life assurance and income protection programs
- Retirement and long-term savings plans
- Global Employee Assistance Program (LifeWorks)
- Flexible, country-specific benefits such as childcare support, gym memberships, and travel benefits
TMF Specialist Job at ICON
Why You Should Join ICON
ICON offers a collaborative, inclusive, and growth-oriented work environment where employees are encouraged to develop professionally and make a meaningful impact on global clinical research. This role provides long-term career progression opportunities within TMF, clinical operations, and regulatory document management. TMF Specialist Job at ICON
Diversity, Equity & Inclusion
ICON is an equal opportunity employer committed to maintaining a workplace free from discrimination and harassment. Reasonable accommodations are available for candidates with disabilities or medical conditions during the application and employment process. TMF Specialist Job at ICON
How to Apply
FAQs
Is this role suitable for senior and junior professionals?
Yes, this role is open to candidates across all experience levels from 1 to 15 years.
Is the job fully remote?
No, this is a hybrid/office-based role in Bangalore or Chennai.
Does the role involve audits?
Yes, TMF Specialists support internal and client audits and inspections.
What qualifications are preferred?
A bachelor’s degree in Life Sciences is preferred, along with TMF experience.
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