Lead TMF Specialist

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Sector: Research and Development, Science and Pharmaceutical
Role: Manager
Contract Type: Permanent
Hours: Full Time

As a Lead TMF Specialist, you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

The role independently maintains the Trial Master Files for assigned studies, participating in end-to-end TMF management activities, including adherence to organizational TMF standards and study-level quality control reviews, and facilitating issue resolution.

1. Ensure TMF completeness and accuracy based on client's SOPs and regulatory requirements
2. Maintain study-level TMFs including QC review, analysis, and vendor oversight (if applicable)
3. Conduct content review of a variety of documents in a short time frame while maintaining consistency and attention to detail
4. Prioritize work accordingly to meet departmental needs and work toward and meet deadlines with some supervision
5. Generate metrics for department and study team usage supporting TMF completeness, timeliness and quality
6. Participate in inspection readiness reviews, preparation activity and inspection conduct
7. Provide guidance and training as applicable to TMF stakeholders; serve as a resource to colleagues on more advanced TMF activities
8. Coordinate onboarding of new staff
9. Participate in and may lead projects that require cross-functional collaboration or involve coordinating system updates

• Bachelor's degree in relevant discipline
• Strong verbal/written communication, presentation skills and interpersonal skills to educate/train project teams and other stakeholders and exchange key information
• Effectively communicates and coordinates activities within the group and other TMF stakeholders
• MS Excel, Word, PowerPoint expertise
• Experience working in a TMF platform
• Experience working in a CTMS platform
• Possess strong critical thinking skills with a focus on inspection readiness

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.

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family's needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organisation. 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 through the form below.

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.