Senior TMF Specialist Job at ICON plc in Chennai for candidates with TMF review, Veeva Vault experience and clinical trial documentation.
Clinical research professionals with experience in Trial Master File (TMF) management have an excellent career opportunity with ICON plc. The organization is currently hiring a Senior TMF Specialist for its Chennai location. This role is designed for professionals who have strong expertise in TMF documentation, periodic file reviews, and regulatory compliance within clinical research operations.
The selected candidate will play a key role in maintaining and managing electronic Trial Master Files (eTMF) to ensure they meet regulatory requirements and are inspection-ready for clinical studies. This position involves collaborating with cross-functional study teams, performing document reviews, and ensuring that all required clinical trial documentation is complete and compliant with global guidelines. Senior TMF Specialist Job at ICON plc
Company Overview
ICON plc is a globally recognized healthcare intelligence and clinical research organization that partners with pharmaceutical, biotechnology, and medical device companies to advance clinical development. The company provides services that help accelerate drug development, improve clinical trial efficiency, and support the delivery of innovative therapies to patients worldwide.
Operating across multiple countries, ICON offers a wide range of services including clinical trial management, data analytics, regulatory support, and healthcare consulting. The organization is known for its commitment to innovation, collaboration, and excellence in clinical research operations. Senior TMF Specialist Job at ICON plc
Job Overview
| Job Detail | Information |
|---|---|
| Company | ICON plc |
| Position | Senior TMF Specialist |
| Job Location | Chennai, Tamil Nadu, India |
| Work Mode | Office with Flex |
| Employment Type | Full Time |
| Department | Clinical Trial Documentation / TMF Management |
| Experience Required | Minimum 5 Years |
| Education | Bachelor’s Degree in Scientific Field |
| Application Mode | Online Application |
| Job Requisition ID | JR146301 |
| Salary | As per company norms |
Job Location & Employment Type
- Location: Chennai, Tamil Nadu, India
- Work Mode: Office-based with flexible work arrangements
- Employment Type: Full-time position
This role requires close collaboration with study teams and documentation specialists to maintain clinical trial documentation systems. Senior TMF Specialist Job at ICON plc
Open Position / Department Details
The Senior TMF Specialist position is part of the clinical trial documentation and quality compliance team responsible for maintaining Trial Master Files for clinical studies.
This department ensures that all clinical trial documentation is properly organized, complete, and compliant with regulatory standards. Professionals in this team work closely with clinical operations teams to ensure that study documentation remains accurate and inspection-ready throughout the lifecycle of clinical trials. Senior TMF Specialist Job at ICON plc
Key Roles & Responsibilities
Professionals selected for this role will manage TMF documentation and ensure regulatory compliance throughout clinical studies. Senior TMF Specialist Job at ICON plc
eTMF Review and Compliance
- Perform comprehensive electronic Trial Master File (eTMF) completeness checks during periodic or milestone reviews.
- Conduct cross-checks and co-dependency checks to ensure document consistency.
- Identify missing documentation and coordinate with study teams to resolve gaps.
Document Management
- Maintain and update the Expected Document List (EDL) when required.
- Ensure that required documents are properly uploaded and organized within the eTMF system.
- Verify that documentation meets regulatory standards and project requirements.
Regulatory Compliance
- Ensure the eTMF is inspection-ready for assigned clinical studies.
- Conduct ALCOEA checks (Attributable, Legible, Contemporaneous, Original, Accurate) to maintain documentation integrity.
- Perform metadata checks to ensure accurate classification and retrieval of documents.
Collaboration with Study Teams
- Work closely with the TMF Lead and clinical study teams to gather information required for document review.
- Communicate with stakeholders to obtain missing documents and close outstanding tasks.
- Provide guidance and support related to TMF documentation processes.
Training and Knowledge Sharing
- Conduct training sessions for internal team members regarding TMF documentation practices.
- Address team queries and provide guidance on documentation requirements.
- Promote best practices for TMF management and compliance.
Process Management and Reporting
- Follow service level agreements (SLAs) and ensure deliverables are completed within agreed timelines.
- Maintain records of TMF review findings and corrective actions.
- Support continuous improvement of documentation processes.
Senior TMF Specialist Job at ICON plc
Eligibility Criteria
Education
Candidates applying for this role should meet the following educational qualifications:
- Bachelor’s degree in a scientific or related field
- Advanced degree in life sciences or healthcare fields is considered an advantage.
Experience
- Minimum 5 years of experience in Trial Master File (TMF) management.
- At least 2–3 years of experience in periodic TMF reviews.
- Experience in performing co-dependency checks, cross checks, and identifying missing documents is required.
Skills Required
Candidates should possess the following technical and professional competencies:
- Strong understanding of TMF regulations and clinical trial documentation requirements
- Experience with Veeva Vault eTMF systems
- Knowledge of electronic document management systems
- Strong proficiency in Microsoft Excel
- Excellent organizational and documentation management skills
- High attention to detail and accuracy
- Strong communication and collaboration abilities
- Ability to manage multiple documentation tasks simultaneously
Understanding clinical research regulatory frameworks and documentation standards is highly beneficial for this role.
Salary & Benefits
- Salary: As per company norms and industry standards.
ICON provides several employee-focused benefits aimed at supporting professional growth and work-life balance. These may include:
- Competitive compensation packages
- Annual leave and wellness benefits
- Health insurance options for employees and families
- Retirement planning programs
- Employee assistance programs for well-being support
- Professional development and training opportunities
- Flexible benefits depending on country-specific policies
Selection Process
The recruitment process typically includes multiple evaluation stages designed to assess candidates’ TMF knowledge and documentation management expertise. Senior TMF Specialist Job at ICON plc
Typical selection stages may include:
- Online application submission
- Resume screening by recruitment team
- HR interview or initial screening
- Technical interview focusing on TMF experience
- Final interview with project or departmental managers
The exact selection process may vary depending on company recruitment policies. Senior TMF Specialist Job at ICON plc
How to Apply
Interested candidates should apply through the official ICON careers portal by submitting their updated resume.
Applicants should ensure their resume highlights:
- TMF management experience
- Experience with periodic TMF reviews
- Knowledge of Veeva Vault or eTMF systems
- Clinical trial documentation expertise
Providing detailed information about TMF experience and documentation skills can improve the chances of being shortlisted. Senior TMF Specialist Job at ICON plc
Why Apply for This Pharma Job?
This role offers a valuable opportunity for professionals who want to build expertise in clinical trial documentation and regulatory compliance. Working with ICON allows employees to gain exposure to global clinical trials and advanced documentation systems used in the pharmaceutical industry.
Advantages of this opportunity include:
- Working with a globally recognized clinical research organization
- Exposure to international clinical trial documentation standards
- Opportunity to work with advanced eTMF systems such as Veeva Vault
- Career growth within clinical research documentation and compliance
- Collaboration with global clinical research teams
For professionals interested in TMF management and clinical research operations, this position provides strong career advancement opportunities. Senior TMF Specialist Job at ICON plc
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent job information platform that shares pharmaceutical and healthcare job updates with job seekers. We are not affiliated with ICON plc or any other organization mentioned in this post. Candidates should verify job details through the official company website before applying. Senior TMF Specialist Job at ICON plc
Final Call-to-Action
Professionals with experience in TMF management and clinical trial documentation are encouraged to apply for this opportunity. Review the eligibility requirements carefully and submit your application through the official ICON careers portal to be considered for the position. Early applications are recommended to improve the chances of selection. Senior TMF Specialist Job at ICON plc
