Global Study Manager

Global Study Manager (Oncology/Hematology - Cell therapy) 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: Contribute to the development of study documents as appropriate as well as any updates/amendments, ensuring template and version compliance. Lead the preparation of country specific agreements, confidentiality agreements, clinical trial applications and other applicable country documents. Manage the set-up of third-party vendors assessing initial statement of work and budget, as well as the change order process. Provide input to data management documents (e.g. Case Report Form, Data Validation Specifications), and interface with data management representatives and sites to facilitate the delivery of study data. Initiate contract/budget requests and track ongoing status; facilitate generation of purchase orders, review vendor invoices and assist in tracking spend against approved budget. Ensure the supply of Investigational product and study materials by liaising with Drug Supply or external service providers as appropriate. Oversight of third party vendors, global / local internal staff and investigator sites to support effective delivery of a study and its regulatory documents from development of the protocol through to the Clinical Study Report. Provide oversight of and support recruitment and data delivery as well as risk mitigation strategies. Assist in the clinical trial insurance process; track approvals, revisions and renewals of certificates. Monitor study conduct and progress, proactively identifying and resolving issues which may impact delivery of the study to the necessary quality, timelines or budget. Support risk management and quality efforts to ensure study compliance. Support set-up, maintenance, closeout and archiving of the Trial Master File (TMF), ensuring continual inspection readiness. Prepare presentation material for meetings, newsletters and websites. Support the study team in the implementation of audits and regulatory inspections. Contribute to review of new/amended/unique SOPs and guidance documents. Your profile: University degree / Bachelor’s degree, preferably in medical or biological science, or discipline associated with Clinical Research, or equivalent experience Minimum of 3 years clinical trial management experience Experience of working with and delivering through strategic partners and 3rd party vendors Experience in oncology/hematology (blood cancers) -- cell therapy experience is highly preferred Experience working on a global level Candidate must reside in Eastern Canada - limited travel may be required Experience in external provider oversight and management 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 apply via our careers site. #J-18808-Ljbffr