Job Description

OverviewICON plc is a world-leading healthcare intelligence and clinical research organization. We\xe2\x80\x99re 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 developmentResponsibilitiesWhat you will be doing:

• Study-level interface with externally managed/outsourced partners for studies planning and delivery
• Lead a cross-functional study team in accordance with EMPOWER to ensure study progress as planned and driving achievement of milestones
• Be primary point of contact for the CRO Project Manager to ensure study delivery according to agreed timelines, budget and quality standards
• Ensure the appropriate level of oversight of the CRO is maintained and documented throughout the lifecycle of the study in accordance with relevant AZ SOPs and guidelines (e.g. Sponsor Oversight Plan, Description of Services)
• Review protocol drafts and input operational perspectives/content into document and authoring team discussions
• Ensure all required External Service Providers (e.g. CROs) are engaged at the study level (including execution of relevant vendors contracts) and are performing to contracted goals, timelines and budget, as well as adequate oversight is documented
• Responsible for study budget management through the study lifecycle and for providing budget progress updates to Dir EPM /Sr Dir EPM including any financial risks and mitigation plans (as part of the ongoing study change control process)
• Oversee study/EAP level performance against agreed upon plans, milestones and key performance metrics, EAP exit strategy
• Identify and report quality issues that have occurred within the study, proactively communicate findings and corrective action plans (CAPA) to relevant stakeholders
• Oversee periodic TMF QC and responsible for review of relevant sections/documents in accordance with SOP/Wiki
• Lead program planning, set up, implementation and delivery of EAP in collaboration with local/regional/global medical and market access teams

QualificationsWhat you will need:

• Bachelor\xe2\x80\x99s degree required preferably in medical or biological science or equivalent by experience
• Relevant industry project management experience in late phase/phase IV studies

Experience in external provider oversight and managementWhat ICON can offer you:Our success depends on the quality of our people. That\xe2\x80\x99s why we\xe2\x80\x99ve 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\xe2\x80\x99s 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\xe2\x80\x99s 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:ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, 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 .Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless \xe2\x80\x93 there\xe2\x80\x99s every chance you\xe2\x80\x99re exactly what we\xe2\x80\x99re looking for here at ICON whether it is for this or other roles.#LI-remote

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