Medical Evidence Specialist

Clinical Trial Associate - Medical Affairs

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

• Executes activities to fulfil sponsor oversight responsibilities and to maintain inspection-readiness, including
• Maintain Study Inspection Readiness ToolsCoordinate and oversee periodic study-level TMF/Master File (MF) QC
• Perform Periodic TMF/MF QC on behalf of Study/EAP Management
• Customization of the study’s Expected Document List (EDL) in collaboration with the CROs
•   Collaborate with extended study team to develop, maintain, and execute activities according to the study Sponsor Oversight Plan
• Ensure appropriate documentation of oversight and inspection-readiness tasks is maintained
• Ensure handover documents are created, signed and filed in TMF
• In collaboration with CRO, support creation, execution and maintenance of TMF/MF Plan
• Supports key study start-up activities, in collaboration with CRO and internal functions as needed
• Support compliance and quality deliverables
• Create and maintain internal study/program trackers and systems as needed, including mailboxes and collaboration forums
• Support budget management activities including

Your profile

• Bachelor’s degree required preferably in medical or biological science or equivalent by experience
• Knowledge and understanding of the clinical study and drug development processes, GCP/ICH guidelines
• Excellent written and verbal communication skills as well as proven collaboration and influencing skills
• Team oriented and flexible; ability to respond quickly to shifting demands and opportunities
• Demonstrated ability to collaborate as well as work independently
• Ability   to    effectively    work    with    Clinical    Research Organizations/External Providers
• Preferred background in medical affairs/investigator initiated studies
• Proven ability to interact widely and effectively within the company across regions, functions and culture
• Ability to manage competing priorities

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