Safeguard the Integrity of Clinical Development
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We are seeking a meticulous and experienced Senior Trial Master File (TMF) Specialist to join our team in Bengaluru. In this critical role, you will be the guardian of clinical trial documentation, ensuring the completeness, quality, and regulatory compliance of the TMF—a cornerstone of every successful study. Your expertise will directly support the advancement of innovative therapies and ensure audit readiness for our global clients.
Your Responsibilities: What You Will Be Doing
- End-to-End TMF Ownership: Manage and maintain the Trial Master File (TMF) for assigned clinical trials from study start-up through to archival, ensuring it is always inspection-ready.
- Quality & Compliance Assurance: Ensure the completeness, accuracy, and timeliness of all TMF documents in accordance with ICH-GCP, regulatory standards, and sponsor-specific requirements.
- Collaboration & Process Management: Work closely with cross-functional study teams (Clinical, Regulatory, Data Management) to facilitate the timely collection, review, and filing of essential documents.
- Audit & Inspection Support: Lead and support internal and external TMF audits and regulatory inspections, addressing findings and implementing corrective actions.
- Expert Guidance & Mentorship: Serve as a subject matter expert, providing guidance and training to internal stakeholders on TMF processes, best practices, and electronic document management systems.
Your Profile: Qualifications & Skills
Education & Experience:
- A Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related scientific field.
- A minimum of 3 years of direct, hands-on experience in TMF management within a CRO, pharmaceutical, or biotechnology setting.
- In-depth knowledge of TMF reference models (e.g., DIA TMF RM), regulatory guidelines, and industry best practices.
Technical Skills & Competencies:
- High proficiency with electronic Trial Master File (eTMF) systems and document management platforms.
- Exceptional organizational skills and an unwavering attention to detail.
- Strong communication and collaboration skills, with the ability to work effectively with global, cross-functional teams.
- Proactive, independent, and able to manage multiple priorities in a fast-paced environment.
Why Join ICON?
Our success depends on the quality of our people. That’s why we prioritize building a diverse culture that rewards high performance and nurtures talent.
We Offer a Competitive Benefits Package Focused on Well-Being:
- Generous Annual Leave entitlements.
- Comprehensive Health Insurance options for you and your family.
- Competitive Retirement Planning offerings to secure your future.
- Global Employee Assistance Programme providing 24/7 confidential support for well-being.
- Life Assurance coverage.
- Flexible, Country-Specific Benefits which may include wellness programs, subsidized travel, and more.
Our Commitment to You:
At ICON, inclusion and belonging are fundamental to our culture and values. We are dedicated to providing an inclusive and accessible environment and are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Ready to be the expert ensuring compliance and quality at the heart of clinical research?
Apply now for the Senior TMF Specialist position in Bengaluru.
We encourage all interested candidates to apply. If you require a reasonable accommodation during the application process, please inform us.
