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

What you will be doing:

• Maintain effective communication with  eTMF Manager (TMF Lead) clinical trial teams (CTT), CRO staff, and eTMF vendor personnel throughout trial start-up, maintenance, and close-out.
• Facilitate and performs periodic completeness reviews of trial TMF content for quality and completeness:
  • Provide orientation and training of the TMF quality review process to the CTT.
  • Determine scope of review: Reviews status of expected document lists (EDLs) and performs risk assessment with CTT to select sites, countries and other criteria.
  • Perform reviews:
    • Ensures documents are present, correctly filed (including indexing location and metadata) and meet all good documentation practice (GDP) and Good Clinical Practice (GCP) standards, and any other Moderna or applicable regulatory requirements
    • Uses cross-document and cross-functional analysis to detect missing documents and/or identify gaps in the TMF that would reduce its effectiveness as a record of trial conduct.
  • Document deviations: Records quality issues for all missing documents, incorrectly filed and/or GDP deviations.
  • Review findings with the TMF Lead and CTT, providing expert insight and action plans to remediate issues.
  • Provide metrics to the TMF Lead for TMF Health reporting as needed.
  • Track and reports on progress to close quality issues on scheduled and ad-hoc basis. Escalates non-compliance per agreed protocol to the Moderna TMF Specialist or trial TMF Lead.
• Review and actions assigned quality issues (QIs) including high risk items, such as record deletion requests.
• Perform routine quality checks of documents uploaded into the eTMFas needed (“QC Review”)
• Attend departmental and trial-specific meetings and discussions, as required.

Complete other TMF document-related tasks as required by the CTT or Clinical Trial Systems Operations team

You are:

• BA/BS required.
• 2+ years of experience in a clinical research environment within the pharmaceutical and biotech industry.
• eTMF completeness and quality oversight experience, e.g. in a TMF or Clinical Operations setting.
• Clear and timely communication skills.
• Proficiency with clinical research documents, their contents, and purpose
• Knowledge of ICH/GCP guidelines and other applicable regulatory rules and guidelines.
• Strong organizational/prioritization skills for the management of workload and attention to detail
• Demonstrated proficiency with eTMF applications.

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

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.

https://careers.iconplc.com/reasonable-accommodations

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.