Evidence Delivery Specialist (Burlington), Northwest Newfoundland/Eastern Labrador …

Evidence Delivery Specialist

ICON plc is a world‑leading healthcare intelligence and clinical research organization. Join us on our mission to shape the future of clinical development. Responsibilities

Execute activities to fulfil sponsor oversight responsibilities and to maintain inspection‑readiness Maintain Study Inspection Readiness Tools Coordinate and oversee periodic study‑level TMF/Master File (MF) QC Perform Periodic TMF/MF QC on behalf of Study/EAP Management Customize the study’s Expected Document List (EDL) in collaboration with the CROsCollaborate 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 PlanSupport 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, includingQualifications

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 skillsTeam 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 studiesProven ability to interact widely and effectively within the company across regions, functions and culture Ability to manage competing priorities Benefits

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 youand your family’s well‑beingLife assurance Flexible country‑specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others Equal Opportunity Statement

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.

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