TMF Specialist

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

Ensures a complete, accurate and high quality Trial Master File (TMF) as the subject matter expert through proper, consistent documentation and proactive partner relationship with the study team.

• Sets up the TMF and TMF index by collaborating with relevant members of the study team and acts as the primary contact and point of escalation for project specific TMF issues.
• Creates, maintains and facilitates sponsor approval of the TMF plan and filing structure and interacts with sponsors / vendors as needed to ensure required TMF deliverables are provided in accordance with study timelines.
• Oversees the quality review process of the study ensuring adherence to TMF Plan, quality standards and study timelines.
• Provides regular status reporting on TMF quality, completeness and audit readiness while identifying and mitigating potential risks and communicating as needed to study team.
• Provides feedback, support and training to study teams in order to build knowledge and awareness of good, quality documentation management practices for clinical trials.
• Ensures all TMF related tasks meet expectations and are delivered in accordance with the contract.
• Manages the life-cycle activities of the TMF in partnership with sponsors/vendors and study team.
• Manages the delivery of a quality, compliant and complete TMF in accordance with sponsor, vendor and company guidelines, standards and regulations.
• Provides reports, analysis and responses to inquiries/requests from sponsors, regulatory agencies, study team members, etc.
• Develops and executes risk mitigation strategies or corrective and preventative actions to document management issues.
• Supports TMF process development, improvement and implementation.
• Supports sponsor portfolio TMF management activities and new business sponsor capabilities audits.
• Supports study-specific audits and sponsor TMF reviews for aligned studies.
• Provides training, coaching and mentoring to less experienced members of the team.

• Bachelor’s Degree or international equivalent
• 3 years of relevant experience

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and 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.