TMF Specialist (all levels)

ICON San Antonio; Chennai; Sur place; INR 700 000 - 1 200 000; Plein temps

Résumé du poste

ICON is a global healthcare intelligence and clinical research organisation committed to advancing patient care. As a TMF Specialist, you will manage the Trial Master File for clinical trials, ensuring regulatory compliance and high-quality documentation across study lifecycles.

You will collaborate with study teams, conduct TMF audits, and guide colleagues on TMF-related matters, while supporting a diverse, inclusive workplace that values integrity and collaboration.

Qualifications

• Bachelor's degree in life sciences, documentation management, or a related discipline.
• Minimum of 3 years of experience in clinical research or TMF management.
• Strong understanding of TMF regulations, guidelines, and best practices.
• Proficiency in electronic document management systems and TMF software.
• Excellent organizational, communication, and attention to detail skills.

Responsabilités

• Managing and maintaining the Trial Master File (TMF) for assigned clinical trials.
• Ensuring the completeness, accuracy, and quality of TMF documents throughout the trial lifecycle.
• Collaborating with study teams to ensure timely collection, processing, and filing of essential documents.
• Conducting TMF audits and inspections to ensure compliance with regulatory standards and sponsor requirements.
• Providing support and guidance on TMF-related matters to internal stakeholders.

Connaissances

TMF management

Regulatory knowledge

Documentation management

Attention to detail

Communication

Formation

Bachelor's degree in life sciences/related

Outils

Electronic document management systems

TMF software

Description du poste

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

As a TMF Specialist at ICON, you will manage the Trial Master File (TMF) for clinical trials, ensuring compliance with regulatory requirements and contribute to the advancement of innovative treatments and therapies.

What You Will Do

Your experience in trial master file management will be key in delivering high‑quality outcomes and mentoring colleagues.

Key Responsibilities Include

• Managing and maintaining the Trial Master File (TMF) for assigned clinical trials.
• Ensuring the completeness, accuracy, and quality of TMF documents throughout the trial lifecycle.
• Collaborating with study teams to ensure timely collection, processing, and filing of essential documents.
• Conducting TMF audits and inspections to ensure compliance with regulatory standards and sponsor requirements.
• Providing support and guidance on TMF-related matters to internal stakeholders.

Your Profile

You will have a strong foundation in trial master file management, with the experience to work independently and guide others.

Required Qualifications And Experience

• Bachelor's degree in life sciences, documentation management, or a related discipline
• Minimum of 3 years of experience in clinical research or TMF management.
• Strong understanding of TMF regulations, guidelines, and best practices.
• Proficiency in electronic document management systems and TMF software.
• Excellent organizational, communication, and attention to detail skills.

What ICON Can Offer You

Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well‑being and work life balance opportunities for you and your family.

Our Benefits Examples Include

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family's needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well‑being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here