TMF Specialist II

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.

The Senior eTMF Specialist is the subject area expert of both eTMF and TMF. He/She is a member of internal center of excellence to maintain process and knowledge, and manages the outsourcing vendor to perform according to the service level agreement and business requirements. He/She supports the eTMF activities of the study teams, oversees the vendor activities, provides eTMF process guidance, interprets the eTMF business rules into system implementation requirements, supports future eTMF enhancement projects including but not limited to the user requirements analysis, change control, validation and change management. The Senior eTMF Specialist has the responsibility to train and transfer the knowledge to eTMF Specialist and Associate eTMF Specialist.

• Give guidance to the study teams on required QC activities, via development of QC guidance documents
• Supports the study teams regarding initial eTMF activities, for example, set-up of study specific TMF Plan for any given study
• Oversees the vendor activities and addresses issues with vendor
• Provides eTMF process guidance and inputs for improvements
• Interprets the TMF business rules into technical system requirements
• Contributes to or leads or supports eTMF enhancement projects
• Provides mentorship and training to new and less experienced staff
• Monitors, plans and coordinates eTMF process improvement implementation
• Responsible for change control and validation activities
• Development of best practices documents, user guides and internal training materials
• Supports GCDO Q&C activities to develop and monitor the eTMF quality metrics
• Performs project management and process governance activities when delegated by eTMF Global Lead
• Participates in eTMF audits and inspections

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 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

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

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, colour, 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.