Country Study Operations Manager - Home-Based (Canada) Join to apply for the Country Study Operations Manager - Home-Based (Canada) role at ICON Strategic Solutions. As a C-SOM you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. En tant que C-SOM, vous rejoindrez la plus grande et la plus complète organisation de recherche clinique au monde, alimentée par l'intelligence en matière de santé.

Responsible for management/oversight of study and regional/country level activities from study startup through conduct and study close May manage the study start up process in countries assigned (where SUPM not assigned) and/or oversee pCRO responsible for these activities as applicable Through the Site Care Partner/Country Trial Manager or pCRO supports the Country/investigator outreach process, site identification and feasibility ensuring countries/sites can meet all study protocol requirements Provides country level input on Startup and Recruitment milestones as provided by pCRO and/or Country Trial Manager/Site Care Partner to Global Study Manager during planning Is accountable for overseeing pCRO and/or Country Trial Manager/Site Care Partner for assigned studies at country level in accordance with the overall project plan, manages and maintains accurate country level plans (e.g. timelines, budget, risk and quality plans) Collaborates with accountable roles to identify and manage deviations and risks in study startup and execution and implements mitigation strategies as required. Is also accountable for resolution of Site Activation escalations to Study Teams including offering options for mitigation Leader of the Local Study Team (core members: Lead Site Care Partners Clinical Trial Assistant; ICL, Site Activation Partner, CTRO and Local Regulatory, Medical Affairs colleagues and other key stakeholders as required) Ensures compliance to relevant Global and Local, internal and external requirements and regulations Ensures timely communication bidirectionally between the global and local study team. Provides protocol level guidance and support to responsible Local Study Team members as applicable.

Liaise with Site Care Partner, Lead Site Care Partner,



Site Activation Partners and Regulatory colleagues in country to agree on submission strategy to Health Authorities and Ethic Committees Utilizes roles in country such as Lead Site Care Partner, and expert roles such as Contracts Leads, Site Activation Partners to provide the Global Teams with local intelligence and operational nuances to be considered Acts as the study level point of contact for all study-level questions for the Local Study Team, ensuring resolution at the lowest possible level, and when needed liaising with and escalating to appropriate global roles/teams Utilizes country intelligence to provide input on country specific risks into preparation of Investigational Quality Management Plan, Study Monitoring Plans, ensures PTMF completeness and oversight of all relevant compliance activities for allocated studies Manages applicable Quality Events with pCRO and local team as applicable and required Coordinates effective site recruitment planning to allow for implementation of plans at the country and site level, consistent with global plan and local targets Responsible to drive and ensure delivery of data cleaning deliverables for pCRO and sites as applicable Provides input on Country level Per Subject Costs, local vendor costs and other fees where applicable Responsible for PTA and SIV report review for reports completed by the Site Care Partner Supports implementation of Pfizer's Site Technology Experience systems (e.g. Platform SIP, Centralized Account Management CAM) A scientific or technical degree is preferred along with knowledge of clinical trial methodology MBA/MS 3+ years of relevant experience Working knowledge of Good Clinical Practice, clinical and regulatory operations and environment in countries under responsibility English is required. Extensive global clinical trial/study management experience Working knowledge of Good Clinical Practices, monitoring,



clinical and regulatory operations Demonstrated study management / leadership experience Demonstrated experience in managing Per Subject Costs, vendor & ancillary, and monitoring costs projections & spend Formation et Éducation Un diplôme scientifique ou technique est préférable, ainsi qu’une connaissance de la méthodologie des études cliniques.

L’anglais est obligatoire. Vaste expérience générale en matière de gestion d’essais et d’études cliniques. Connaissance pratique des bonnes pratiques cliniques, de la surveillance et des opérations cliniques et réglementaires.

Expérience démontrée en gestion d’études et/ou en matière de leadership. Expérience démontrée en supervision des CRO. Expérience démontrée dans la gestion des coûts par participant(e), des fournisseurs et des accessoires, et dans le suivi des projections et des dépenses des coûts.

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.

A range of health insurance offerings to suit you and your family’s 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’s 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 advantages of working at ICON: careers.iconplc.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.

📌 Responsable de Performance Opérationnelle Régional H/F (Ottawa)
🏢 ICON Strategic Solutions
📍 Ottawa