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    Job · 21050544

    CHENNAI · FULLTIME

    TMF Specialist (all levels)

    IS

    icon san antonio

    Chennai · onsite · Posted 8d ago

    Sourced fromFoundit
    Not disclosed3–5 yrsfulltimeChennai

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    Section · 01

    About this role

    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.

    Visit our careers site to read more about the benefits ICON offers.

    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

    Interested in the role, but unsure if you meet all of the requirements We would encourage you to apply regardless – there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.

    Are you a current ICON Employee Please click here to apply

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    Section · 02

    Skills

    Electronic document management systemsTMF software

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