Study Operations Manager - Canada Remote
PRA Health Sciences
Req #: 120332
Type: Canada-West
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Overview: 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. Responsibilities: What you will be doing: 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, 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 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 lowest possible level, and when needed liaising with and escalating to appropriate global roles/teams * Follows up on region/country level issue status to ensure resolution. * Identifies country level trends to improve deliverables processes as needed * 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 * Ensures audit/Inspection readiness during start-up and conduct * 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 * May act as a Subject Matter Expert * May lead operational effectiveness initiatives at country or regional level * 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. Shared Investigator Platform SIP, Centralized Account Management CAM) * Support to EC/RA and other relevant (e.g. radiation, biobank) submissions and deficiency/query responses for initial and subsequent CTA submissions within required timelines * Drives pCRO and/or applicable internal study team members to ensure PTMF set up meets study requirements, and maintains oversight of PTMF completeness * Provides country level documents to PTMF and maintains oversight of Investigator Site File (ISF) reconciliation and completeness actions * Ensures pCRO and/or applicable internal study team members maintain appropriate level IP/equipment/ancillary supplies management including Import/Export License management with the support of Clinical Trial Assistants and other roles as required * Supports implementation of new tools and technologies (e.g. eConsent, eISF, Remote Source Access, remote SDV/SDR, iConnect, implementation of protocol required decentralized trial options etc.) * Support Identification, contract development and management of local vendors or facilities as per protocol * Investigator Meeting support and management including doing presentations as appropriate * Management of local Investigator Meetings including doing presentations as appropriate Ce que vous ferez : Responsable de la gestion / supervision de l'étude et des activités au niveau régional / pays, depuis le démarrage de l'étude jusqu'à sa réalisation et sa clôture * Peut gérer le processus de démarrage de l'étude dans les pays assignés (lorsqu'un SUPM n'est pas assigné) et / ou superviser le pCRO responsable de ces activités le cas échéant * Grâce au Partenaire de Soins du Site / Responsable d'Étude Pays ou pCRO, soutient le processus de sensibilisation des pays / enquêteurs, l'identification et la faisabilité des sites en s'assurant que les pays / sites peuvent satisfaire à toutes les exigences du protocole de l'étude * Fournit des contributions au niveau du pays sur les jalons de Démarrage et de Recrutement tels que fournis par le pCRO et / ou le Responsable d'Étude Pays / Partenaire de Soins du Site au Responsable d'Étude Mondiale lors de la planification * Est responsable de la supervision du pCRO et / ou du Responsable d'Étude Pays / Partenaire de Soins du Site pour les études assignées au niveau national conformément au plan de projet global, gère et maintient des plans au niveau national précis (par exemple, délais, budget, plans de risque et de qualité) * Collabore avec les rôles responsables pour identifier et gérer les écarts et les risques lors du démarrage et de l'exécution de l'étude et met en œuvre des stratégies d'atténuation si nécessaire. Est également responsable de la résolution des escalades d'Activation de Site auprès des Équipes d'Étude, y compris la proposition d'options pour l'atténuation * Leader de l'Équipe d'Étude Locale (membres clés : Partenaires de Soins de Site (Lead), Assistant d'Essai Clinique, membres ad hoc : ICL, Partenaire d'Activation de Site, CTRO et collègues de Réglementation Locale, Affaires Médicales et autres parties prenantes clés selon les besoins) * Assure la conformité aux exigences et réglementations internes et externes, globales et locales pertinentes * Assure une communication bilatérale en temps opportun entre l'équipe d'étude mondiale et locale. * Fournit des conseils et un soutien au niveau du protocole aux membres responsables de l'Équipe d'Étude Locale, le cas échéant. * Faire le lien avec le Partenaire de Soins du Site, le Partenaire Principal de Soins du Site, les Partenaires d'Activation du Site et les collègues en Réglementation dans le pays pour convenir d'une stratégie de soumission auprès des Autorités de Santé et des Comités d'Éthique * Utiliser des rôles dans le pays tels que Partenaire Principal de Soins du Site, et des rôles d'expert te
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