TMF Specialist

TMF

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

JOB FUNCTIONS/RESPONSIBILITIES

• Maintain effective communication with clinical trial teams and CRO staff throughout trial start-up, maintenance, close-out, and archive
• eTMF Health: Manage open Quality Issue (QI) lists for assigned trials to ensure documents which fail TMF quality control and/or TMF quality review are effectively remediated.
• Closes and reassigns QIs as necessary.
• eTMF Health: Manage Expected Document Lists (EDL) and counts for the life of assigned trials partnering with the Clinical Trial Team (CTT) and CRO team.
• Escalate non-compliance with EDL business process to the eTMF Manager as needed.
• eTMF Health: Provide scheduled and ad-hoc analysis and metrics on TMF Health for eTMF Managers and CTT/CRO teams on assigned trials.
• Be responsible for TMF activities for assigned trials including:
• Supporting TMF document filing into Moderna eTMF system.
• Maintaining the naming and filing guide specific to TMF documents.
• Conducting ad-hoc quality checks and review of document content uploaded into the eTMF.
• Responding to inquiries regarding TMF management and contents.
• Supporting inspection/audit preparation and remediation activities.
• Attend departmental and trial-specific meetings and discussions, as required.
• Maintain up to date knowledge of the TMF Reference Model, industry best practices and regulatory requirements.
• Performs general administrative tasks related to their assigned trials.
• Completes other TMF document-related tasks as required by the eTMF Manager or department head.

EXPERIENCE & SKILLS

• Minimum B.A./B.S. degree preferably in science or healthcare.
• 1+ years experience in eTMF document management (in a specialized team or as a member of a clinical trial team) is an advantage.
• Strong organizational/prioritization skills for the management of workload and attention to detail.
•  Basic knowledge in DIA TMF Reference Model

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, 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 site to read more about the benefits ICON offers.

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 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