ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
ICON plc est un chef de file mondial en matière de soins de santé intelligents et de recherches cliniques. De la molécule au médicament, nous faisons progresser la recherche clinique en offrant des services externalisés aux entreprises pharmaceutiques, biotechnologiques, et d’équipement médical, ainsi qu’aux organismes gouvernementaux et de santé publique.
En plaçant nos patients au cœur de toutes nos activités, nous contribuons à accélérer le développement de médicaments et de dispositifs qui sauvent des vies et améliorent la qualité de vie.
Nos employé(e)s sont au cœur de notre culture et constituent la force motrice de notre succès. Les employé(e)s d’ICON ont pour mission de réussir et sont animé(e)s d’une passion qui garantit que ce que nous faisons, nous le faisons bien.
What you will be doing:
- Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality.
- Leads and optimises the performance of the Local Study Team(s) at country level ensuring compliance with Procedural Documents, ICH-GCP and local regulations.
- Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality.
- Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks.
- Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study. Works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations.
- Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in AZ clinical studies financial system by regular checks of the system and financial reports (as agreed with Director, SMM/ Director, Country Head.
- Ensures timely preparation of local Master CSA (including site budget) and amendments as needed.
- Ensures timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs, as required, including any relevant translations, and in line with relevant SOPs and local regulations.
- Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enrol, and in line with SOPs.
- Plans and coordinates applicable local drug activities (from local purchase or reimbursement to drug destruction).
- Sets up and maintains the study in CTMS at study country level as well as local websites as required by local laws and regulations.
- Oversees, manages and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans.
- Reviews monitoring visit reports (as required and following SOPs) and pro-actively advices the monitor(s) on study related matters.
- Performs any required co-monitoring, Accompanied Site Visits/training visits with study CRAs.
- Proactively identifies risks and facilitates resolution of complex study problems and issues.
- Organises regular Local Study Team meetings on an agenda driven basis.
- Actively works towards achieving good personal relationships with all Local Study Team members, sites’ staff and global stakeholders.
- Reports study progress/update to the Global Study Associate Director/ Global Study Team including SMM Lead.
- Contributes to patient recruitment strategy including regular communication with participating Investigators as necessary.
- Develops, maintains and reviews risk management plan on country study level: proactively manages sites, stakeholders, local and global vendors and customers to ensure risks are timely identified, mitigated and managed.
- Communicates and co-ordinates regularly with National Co-ordinating Investigator / National Lead Investigator on recruitment and other study matters, if applicable.
- Plans and leads National Investigator meetings, in line with local codes, as required.
- Assists in forecasting study timelines, resources, recruitment, budget, study materials and drug supplies.
- Ensures relevant systems required to facilitate business critical, license to operate activities (for example, Safety Reporting, Regulatory submissions, Clinical Trial Transparency) are set-up, updated and access is organised at country level.
- Ensures accurate payments related to the study are performed according to local regulations and agreements.
- Participates in training and coaching new members of the Local Study Team ensuring compliance with ICH-GCP and Procedural Documents.
- Ensures completeness of the eTMF and ensures essential documents are uploaded in a timeline bmanner to maintain the eTMF “Inspection Ready”.
- Ensures that all study documents are ready for final archiving and completion of local part of the eTMF.
- Plans and leads activities associated with audits and regulatory inspections in liaison with CQAD and QA.
- Provides input to process development and improvement.
- Provides regular information to Line Managers at country level on study/ies and planned study milestones/key issues.
- Updates Line Managers about the performance of the CRAs/CSAs.
- Ensures that study activities at country level comply with local policies and code of ethics.
- Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.
- Ensures compliance with company Code of Ethics, company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).
- Collaborates with local Medical Affairs team.
- Supports SMM in different initiatives (local, regional or global) as agreed with the SMM Line Management.
Le/la gestionnaire de l’essai clinique (GEC) est responsable de la réalisation de tous les aspects cliniques de l’étude. Le/la GEC supervise la partie clinique du budget, élabore des plans et des outils de suivi, forme les associés de recherche clinique (ARC), pilote les activités d’inscription et de démarrage de l’étude, passe en revue les rapports de déplacement, met en œuvre des plans d’action correctifs et préventifs, assure la liaison avec le commanditaire, les fournisseurs et les équipes interfonctionnelles, identifie et atténue les risques susceptibles d’avoir un impact sur la prestation clinique, et fournit des rapports et des mesures sur toutes les activités cliniques. Le/la GEC participera également aux réunions avec les promoteurs et les chercheurs, ainsi qu’aux réunions de défense des offres.
You are:
- Bachelor degree in related discipline, preferably in life science, or equivalent qualification (*).
- Minimum 3 years of experience in Development Operations (CRA, SrCRA) or other related fields (Medical Affairs-led or Academic-led studies).
- Good knowledge of international guidelines ICH- GCP as well as relevant local regulations.
- Excellent project management skill
- Excellent team building and interpersonal skills
- Excellent organisational skills
- Excellent verbal and written communication skills
- Excellent ability to prioritize and handle multiple tasks
- Excellent attention to details
- Excellent knowledge of spoken and writtenEnglish
- Good negotiation skills
- Good ability to learn and to adapt to work with IT systems.
- Location: Canada - East
Vous aurez besoin de :
• Un baccalauréat en sciences de la santé, en sciences de la vie ou dans un autre domaine d’études pertinent
• 5 ans et plus d’expérience en recherche clinique, requis
• 1 à 2 ans d’expérience comme GEC, fortement préférés
• 2 ans et plus d’expérience en suivi, fortement préférés
• Solide connaissance du processus de développement des médicaments
• Solide connaissance et application pratique des exigences réglementaires pertinentes
• Excellentes compétences en gestion de projet
• Excellentes compétences en leadership et capacités d’influence
• Excellentes compétences en résolution de problèmes
• Excellentes capacités de pensée critique
• Maîtrise de la suite Microsoft Office et des applications de collaboration d’entreprise
• Maîtrise de l’anglais (capacité à lire, écrire, parler), requise
• Déplacement jusqu’à un maximum de 10 %, requis
Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and 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.
Chez ICON, notre objectif est de vous offrir une rémunération globale complète et concurrentielle qui comprend non seulement un excellent salaire de base, mais aussi un large éventail de programmes de rémunération variable et de reconnaissance. De plus, nous offrons des avantages sociaux, des mesures de soutien et des initiatives de bien-être de première qualité, afin de vous soutenir, vous et votre famille, à toutes les étapes de votre carrière, maintenant et à l’avenir.
ICON, y compris ses filiales, est un employeur inclusif qui offre des chances égales et s’engage à offrir un cadre de travail exempt de discrimination et de harcèlement. Tous et toutes les candidat(e)s qualifié(e)s bénéficieront d’une considération égale pour l’emploi, sans égard à la race, la couleur, la religion, le sexe, l’orientation sexuelle, l’identité de genre, l’origine nationale, le handicap ou le statut d’ancien combattant protégé.
Si, en raison d’un problème de santé ou d’un handicap, vous avez besoin d’un aménagement raisonnable pour toute partie du processus de candidature, ou pour exécuter les fonctions essentielles d’un poste, veuillez nous en informer au moyen du formulaire ci-dessous.
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