Clinical Document Specialist
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.
We are currently seeking a Clinical Document Specialist to join our diverse and dynamic team. As a Clinical Document Specialist at ICON, you will support the Clinical Operations department as the primary person responsible for supporting the Clinical Study Team (CST) with trial document management, conducting Quality Control checks (QC), and filing of documentation in the Veeva electronic Trial Master File (eTMF). This position will work closely with CST Functional Area Leads (FALs) and the Clinical Quality team.
What you will be doing
Support Clinical Operations and the CST with day-to-day lifecycle management of documentation including filing and classification of trial artifacts in the Veeva eTMF for clinical trials
Serve as TMF contact and Subject Matter Expert for the clinical study team and supporting cross-functional departments including TMF process education to ensure high quality documentation
Classify and index electronic TMF (eTMF) and clinical trial documentation with accurate attributes and metadata according to company standards, Good Clinical Documentation Practices, and project-level Trial Master File Plan and Index
Monitor TMF health/report metrics throughout the study according to TMF plan and deliver KPI reports and dashboard to the study team
Execute planned and ad hoc Quality Control (QC) procedures, identify and record quality issues; provide solutions and resolve issues with relevant FALs and in accordance with Alermes SOP ; identify documentation trends and perform corrective training to CST members as needed based on TMF QC findings
Support audit/inspection activities, internal Compliance/Quality procedures and process improvement
Execute change management to ensure consistent application and best practices of revised standards, processes, and systems functionality across Clinical Study Teams
Develop, review, or update trial-level TMF Plans and Trial Index.
Providing best practice guidance and support to ongoing and ad-hoc TMF projects and initiatives
Your profile
Bachelor's Degree with 4+ years clinical experience including organizing and coordinating electronic Trial Master Files for clinical trials
High level of competency with Veeva VAULT eTMF and knowledge of the TMF Reference Model, supported by DIA
Excellent organizational and problem-solving skills, able to work independently
Efficient and effective time management skills with ability to successfully manage competing priorities.
Strong attention to detail
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, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. 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
