ICON Hiring for TMF Specialist I Job in Bangalore to support clinical trial documentation, TMF management, and regulatory compliance activities.
Introduction
ICON plc, one of the world’s leading healthcare intelligence and clinical research organizations, is inviting talented professionals to apply for the role of TMF Specialist I in Bangalore, India. ICON is globally recognized for its scientific excellence, operational quality, and commitment to advancing clinical development. Joining ICON means becoming part of a collaborative, diverse, and innovation-driven environment that supports continuous learning and long-term career growth. ICON Hiring for TMF Specialist I Job
The TMF Specialist I position is ideal for candidates interested in clinical documentation, Trial Master File (TMF) processes, and regulatory documentation management. TMF plays a crucial role in every clinical trial, ensuring that studies are audit-ready, compliant with regulatory standards, and equipped with complete and accurate documentation throughout the life cycle of a study. ICON Hiring for TMF Specialist I Job
In this long-format, SEO-optimized article, you will find detailed information on job responsibilities, qualifications, benefits, company culture, and the complete step-by-step application process. ICON Hiring for TMF Specialist I Job
Key Highlights
| Key Information | Details |
|---|---|
| Company | ICON plc |
| Role | TMF Specialist I |
| Location | Bangalore / Bengaluru, India |
| Job ID | JR140395 |
| Category | Regulatory Document Management |
| Employment Type | Full-Time |
| Experience Required | Preferred experience in clinical research or document management |
| Education Required | Bachelor’s degree in relevant discipline |
| Work Model | Office-based |
About ICON plc
ICON plc is a globally trusted CRO delivering healthcare intelligence, clinical development expertise, and scientific innovation to pharmaceutical, biotechnology, and medical device industries. With operations across multiple continents and thousands of employees worldwide, ICON has contributed to transforming clinical trials, supporting regulatory submissions, and accelerating drug development for some of the world’s most impactful therapies. ICON Hiring for TMF Specialist I Job
ICON places a strong emphasis on quality, diversity, and performance. The company maintains an inclusive culture where team members can grow, innovate, and contribute meaningfully to clinical research. ICON continues to lead the industry through advanced analytics, modern digital solutions, and unwavering commitment to scientific excellence. ICON Hiring for TMF Specialist I Job
Role Overview: TMF Specialist I
The role of TMF Specialist I centers around supporting the maintenance, organization, and management of the Trial Master File (TMF). TMF is a critical component of clinical trials, storing all essential regulatory and study documents that demonstrate compliance with Good Clinical Practice (GCP), ICH guidelines, sponsor requirements, and global regulatory expectations. ICON Hiring for TMF Specialist I Job
As a TMF Specialist I, you will assist with document review, uploading, indexing, QC, and maintaining accurate filing within the TMF system. You will collaborate with cross-functional teams and ensure that documentation is complete, audit-ready, and accessible throughout the study’s lifecycle.
This entry-level to early-career position is ideal for candidates who want to grow in TMF operations, document management, compliance, and clinical trial support functions. ICON Hiring for TMF Specialist I Job
Detailed Responsibilities
1. Learn and Support TMF Documentation Processes
You will gain a deep understanding of TMF structure, document classification, metadata assignment, and essential documents required throughout clinical trial phases.
2. Assist in Document Management Activities
Responsibilities include:
- Uploading and indexing clinical trial documents
- Reviewing documents for completeness and accuracy
- Ensuring timely filing of essential documents
- Performing basic quality checks to confirm compliance
3. Support Client Services Contracts
You will assist in meeting TMF-related commitments outlined in client contracts, helping ensure accurate and timely documentation delivery.
4. Ensure Compliance with Procedures and Requirements
This involves adhering to:
- ICON’s internal SOPs
- Sponsor SOPs
- Regulatory expectations for TMF
- Study-specific guidelines
- ICH-GCP standards
5. Maintain TMF Organization and Structure
You will help keep TMF well organized, consistently updated, and aligned with audit and inspection readiness requirements.
6. Collaborate with Cross-Functional Teams
Regular communication with clinical operations, regulatory teams, project managers, and document specialists ensures smooth TMF operations.
7. Support Continuous Improvements
Providing suggestions, identifying documentation issues, or flagging gaps will help improve TMF quality and completeness.
Your Profile and Eligibility Criteria
Educational Requirements
- Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, Medical Documentation, or any relevant discipline
- Higher qualifications are an advantage but not mandatory
Experience Requirements
- Prior experience in clinical research, TMF operations, or document management is preferred
- Freshers with strong academic backgrounds and documentation interest are also encouraged to apply
Key Skills Required
- Strong attention to detail
- Excellent organizational skills
- Good communication (written and verbal)
- Ability to collaborate effectively
- Strong ability to follow guidelines and SOPs
- Ability to work in a structured, team-based environment
- Good understanding of document lifecycle and clinical terminology (preferred)
Why Work at ICON?
ICON offers a people-first, growth-oriented, and flexible working environment. Employees are encouraged to innovate, learn continuously, and grow their careers at their own pace with strong support systems. ICON Hiring for TMF Specialist I Job
ICON Benefits Include:
- Competitive salary and performance-based rewards
- Annual leave entitlements and holiday benefits
- Health insurance options tailored to employee needs
- Retirement planning and savings support
- Global Employee Assistance Program offering 24/7 support
- Life assurance
- Well-being programs, including mental health and physical fitness support
- Optional benefits like travel discounts, childcare vouchers, gym membership discounts, and more
Commitment to Diversity and Inclusion
ICON believes in equal opportunity and fairness. The company is committed to: ICON Hiring for TMF Specialist I Job
- Creating an inclusive workplace
- Encouraging applicants regardless of background
- Offering accommodations for individuals with disabilities
- Eliminating discrimination based on gender, race, religion, nationality, etc.
Even if a candidate doesn’t meet every single requirement, ICON encourages applying—because the right talent can be discovered from unexpected profiles. ICON Hiring for TMF Specialist I Job
Work Environment and Culture
The TMF Specialist role is office-based, offering opportunities to collaborate closely with peers and senior TMF professionals. You will be part of a team that values accuracy, teamwork, and continuous development. ICON’s culture encourages learning, questions, innovation, and personal ownership of outcomes. ICON Hiring for TMF Specialist I Job
How to Apply
Interested candidates can apply directly by visiting ICON’s official careers page and searching for Job ID JR140395 – TMF Specialist I. After submitting your CV, the hiring team—managed by Swathy Anandan—will review your application. If shortlisted, you will be contacted for the next steps, which may include assessments or interviews. ICON Hiring for TMF Specialist I Job
Ensure your resume highlights:
- Documentation experience
- Clinical research exposure
- Attention to detail
- Knowledge of GCP, ICH, or TMF processes
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Note: This job information is sourced from publicly available official sources. We share it for reference purposes only and do not claim ownership of the job posting.
