Manager, TMF Operations - US Remote

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. 

What you will be doing:

• Maintains effective communication with clinical study teams, CRO staff, and eTMF vendor personnel throughout study start-up, maintenance, and close-out.
• Supports TMF document filing into Moderna eTMF system.
• Authors initial TMF plans
• Maintains a naming and filing guide specific to TMF documents.
• Performs routine quality checks of documents uploaded into the eTMF.
• Responds to inquiries regarding TMF management and contents.
• Attends departmental and study-specific meetings and discussions, as required.
• Runs routine eTMF reports and monitors TMFs for completeness and trends.
• Supports system updates by participating in user acceptance testing and system enhancement discussions.
• Completes other TMF document-related tasks as required by the study teams or the Clinical Trial Excellence department.

You are:

• BA/BS required; Advanced degree preferred.
• 5+ years of experience in a clinical research environment within the pharmaceutical and biotech industry.
• eTMF document management experience.
• Clear and timely communication skills.
• Proficiency with clinical research documents, their contents, and purpose, and working knowledge of GCP and regulatory requirements.
• 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.