Job Title

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 worlds largest & most comprehensive clinical research organisation, powered by healthcare intelligence.En tant que C-SOM, vous rejoindrez la plus grande et la plus complte organisation de recherche clinique au monde, alimente par l'intelligence en matire de sant.ResponsibilitiesResponsible for management/oversight of study and regional/country level activities from study startup through conduct and study closeMay manage the study start up process in countries assigned (where SUPM not assigned) and/or oversee pCRO responsible for these activities as applicableThrough 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 requirementsProvides 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 planningIs 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 mitigationLeader of the Local Study Team (core members: Lead Site Care Partners Clinical Trial Assistant; ad hoc members: 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 regulationsEnsures 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 CommitteesUtilizes 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 consideredActs 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/teamsFollows up on region/country level issue status to ensure resolution.Identifies country level trends to improve deliverables processes as neededUtilizes 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 studiesEnsures audit/Inspection readiness during start-up and conductManages applicable Quality Events with pCRO and local team as applicable and requiredCoordinates effective site recruitment planning to allow for implementation of plans at the country and site level, consistent with global plan and local targetsResponsible to drive and ensure delivery of data cleaning deliverables for pCRO and sites as applicableProvides input on Country level Per Subject Costs, local vendor costs and other fees where applicableMay act as a Subject Matter ExpertMay lead operational effectiveness initiatives at country or regional levelResponsible for PTA and SIV report review for reports completed by the Site Care PartnerSupports implementation of Pfizer's Site Technology Experience systems (e.g. Platform SIP, Centralized Account Management CAM)You AreRelevant operational clinical trial experienceA scientific or technical degree is preferred along with knowledge of clinical trial methodologyBA/BS 5+ years of relevant experienceMBA/MS 3+ years of relevant experienceBS/BSc/MS/MScWorking knowledge of Good Clinical Practice, clinical and regulatory operations and environment in countries under responsibilityEnglish is required.SkillsExtensive global clinical trial/study management experienceWorking knowledge of Good Clinical Practices, monitoring, clinical and regulatory operationsPrior Experience Preferred: Demonstrated study management / leadership experience Demonstrated oversight of CROs Demonstrated experience in managing Per Subject Costs, vendor & ancillary, and monitoring costs projections & spend Formation et ducationExprience pertinente en matire dessais cliniques oprationnels.Un diplme scientifique ou technique est prfrable, ainsi quune connaissance de la mthodologie des tudes cliniques.Un B.A. ou B.S. avec plus de 5 ans dexprience pertinente.Un M.B.A. ou M. Sc. avec plus de 3 ans dexprience pertinente.B.S., B. Sc., M.S. ou M. Sc.Connaissance pratique des bonnes pratiques cliniques, des oprations cliniques et rglementaires et de lenvironnement des pays responsables des tudes.Langlais est obligatoire.ComptencesVaste exprience gnrale en matire de gestion dessais et dtudes cliniques.Connaissance pratique des bonnes pratiques cliniques, de la surveillance et des oprations cliniques et rglementaires.Exprience pralable souhaite : Exprience dmontre en gestion dtudes et/ou en matire de leadership. Exprience dmontre en supervision des CRO. Exprience dmontre dans la gestion des cots par participant(e), des fournisseurs et des accessoires, et dans le suivi des projections et des dpenses des cots. What ICON Can Offer YouOur success depends on the quality of our people. Thats why weve 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.Various annual leave entitlementsA range of health insurance offerings to suit you and your familys needsCompetitive retirement planning offerings to maximise savings and plan with confidence for the years aheadGlobal 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 familys well-beingLife assuranceFlexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among othersVisit our careers website to read more about the benefits of working at ICON: careers.iconplc.com/benefitsICON, including its subsidiaries, is an inclusive employer that provides equal opportunities and a discrimination-free workplace. 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.Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless theres every chance youre exactly what were looking for here at ICON whether it is for this or other roles. #J-18808-Ljbffr