Job Description

Country Study Operations Manager - Home Based (Canada)
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:

Responsible 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 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'etude et des activites au niveau regional / pays, depuis le demarrage de l'etude jusqu'a sa realisation et sa cloturePeut gerer le processus de demarrage de l'etude dans les pays assignes (lorsqu'un SUPM n'est pas assigne) et / ou superviser le pCRO responsable de ces activites le cas echeant Grace au Partenaire de Soins du Site / Responsable d'Etude Pays ou pCRO, soutient le processus de sensibilisation des pays / enqueteurs, l'identification et la faisabilite des sites en s'assurant que les pays / sites peuvent satisfaire a toutes les exigences du protocole de l'etude Fournit des contributions au niveau du pays sur les jalons de Demarrage et de Recrutement tels que fournis par le pCRO et / ou le Responsable d'Etude Pays / Partenaire de Soins du Site au Responsable d'Etude Mondiale lors de la planification Est responsable de la supervision du pCRO et / ou du Responsable d'Etude Pays / Partenaire de Soins du Site pour les etudes assignees au niveau national conformement au plan de projet global, gere et maintient des plans au niveau national precis (par exemple, delais, budget, plans de risque et de qualite) Collabore avec les roles responsables pour identifier et gerer les ecarts et les risques lors du demarrage et de l'execution de l'etude et met en oeuvre des strategies d'attenuation si necessaire. Est egalement responsable de la resolution des escalades d'Activation de Site aupres des Equipes d'Etude, y compris la proposition d'options pour l'attenuation Leader de l'Equipe d'Etude Locale (membres cles : Partenaires de Soins de Site (Lead), Assistant d'Essai Clinique, membres ad hoc : ICL, Partenaire d'Activation de Site, CTRO et collegues de Reglementation Locale, Affaires Medicales et autres parties prenantes cles selon les besoins) Assure la conformite aux exigences et reglementations internes et externes, globales et locales pertinentes Assure une communication bilaterale en temps opportun entre l'equipe d'etude mondiale et locale. Fournit des conseils et un soutien au niveau du protocole aux membres responsables de l'Equipe d'Etude Locale, le cas echeant. 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 collegues en Reglementation dans le pays pour convenir d'une strategie de soumission aupres des Autorites de Sante et des Comites d'Ethique Utiliser des roles dans le pays tels que Partenaire Principal de Soins du Site, et des roles d'expert tels que les Responsables des Contrats, les Partenaires d'Activation du Site pour fournir aux Equipes Globales des informations locales et des nuances operationnelles a prendre en compte Agir en tant que point de contact au niveau de l'etude pour toutes les questions liees a l'etude pour l'Equipe d'Etude Locale, en garantissant la resolution au niveau le plus bas possible, et le cas echeant, en faisant le lien et en escaladant vers les roles/equipes globales appropries Suivre l'etat des problemes au niveau regional/pays pour garantir leur resolution. Identifier les tendances au niveau national pour ameliorer les processus de livraison selon les besoins. Utilise l'intelligence pays pour fournir des contributions sur les risques specifiques a chaque pays dans la preparation du Plan de Gestion de la Qualite d'Investigational, des Plans de Suivi d'Etude, assure la completude du PTMF et la supervision de toutes les activites de conformite pertinentes pour les etudes attribuees. Assure la preparation a l'audit/inspection lors du demarrage et de la conduite de l'etude.

o Gere les Evenements de Qualite applicables avec le pCRO et l'equipe locale, selon le besoin et les exigences.o Coordonne une planification efficace du recrutement sur site afin de permettre la mise en oeuvre des plans au niveau national et local, en accord avec le plan global et les objectifs locaux.Responsable de conduire et d'assurer la livraison des livrables de nettoyage des donnees pour le pCRO et les sites, selon le besoin. Fournit des contributions sur les Couts par Sujet au niveau du Pays, les couts des fournisseurs locaux et d'autres frais le cas echeant Peut agir en tant qu'expert en la matiere. Peut diriger des initiatives d'efficacite operationnelle au niveau national ou regional Responsable de l'examen des rapports PTA et SIV pour les rapports completes par le Partenaire de Soins de Site Soutient la mise en oeuvre des systemes d'Experience Technologique de Site de Pfizer (par exemple, la Plateforme d'Investigateur Partagee SIP, la Gestion Centralisee des Comptes CAM) Soutien aux soumissions EC/RA et autres soumissions pertinentes (par exemple, radiotherapie, biobanque) et reponses aux non-conformites/questions pour les soumissions CTA initiales et ulterieures dans les delais requis Conduit pCRO et/ou membres internes de l'equipe d'etude applicables pour s'assurer que la mise en place du PTMF repond aux exigences de l'etude, et maintient une supervision de l'exhaustivite du PTMF Fournit des documents a l'echelle nationale au PTMF et maintient une supervision de la reconciliation et des actions d'exhaustivite du Dossier de Site de l'Investigateur (ISF) S'assure que le pCRO et/ou les membres internes de l'equipe d'etude concernes maintiennent un niveau approprie de gestion des IP/equipements/fournitures auxiliaires, y compris la gestion des licences d'importation/exportation, avec le soutien des assistants d'essai clinique et d'autres roles si necessaire. Soutient la mise en oeuvre de nouveaux outils et technologies (par exemple, eConsent, eISF, acces a distance aux sources, SDV/SDR a distance, iConnect, mise en oeuvre des options d'essai decentralisees requises par le protocole, etc.). Soutien a l'identification, au developpement de contrats et a la gestion de fournisseurs ou d'installations locaux conformement au protocole. Soutien et gestion des reunions d'investigateurs, y compris la realisation de presentations si approprie. Gestion des reunions d'investigateurs locaux, y compris la realisation de presentations si approprie.

You are:
Relevant operational clinical trial experience

A scientific or technical degree is preferred along with knowledge of clinical trial methodology BA/BS 5+ years of relevant experience MBA/MS/ 3+ years of relevant experience BS/BSc/MS/MSc Working knowledge of Good Clinical Practice, clinical and regulatory operations and environment in countries under responsibility English is required.
Skills:Extensive global clinical trial/study management experience Working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations Prior 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 education :Experience pertinente en matiere d'essais cliniques operationnels. Un diplome scientifique ou technique est preferable, ainsi qu'une connaissance de la methodologie des etudes cliniques. Un B.A. ou B.S. avec plus de 5 ans d'experience pertinente. Un M.B.A. ou M. Sc. avec plus de 3 ans d'experience pertinente. B.S., B. Sc., M.S. ou M. Sc. Connaissance pratique des bonnes pratiques cliniques, des operations cliniques et reglementaires et de l'environnement des pays responsables des etudes. L'anglais est obligatoire.

Competences :Vaste experience generale en matiere de gestion d'essais et d'etudes cliniques. Connaissance pratique des bonnes pratiques cliniques, de la surveillance et des operations cliniques et reglementaires. Experience prealable souhaitee : + Experience demontree en gestion d'etudes et/ou en matiere de leadership.
+ Experience demontree en supervision des CRO.
+ Experience demontree dans la gestion des couts par participant(e), des fournisseurs et des accessoires, et dans le suivi des projections et des depenses des couts.


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, 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 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
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.