Study Delivery Lead - Home- Based (Canada)
- Canada
- ICON Strategic Solutions
- Clinical Trial Management
- Remote
About the role
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As a Study Delivery Lead, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
- This position within GCD is accountable end to end from CSI (Commit to Study Initiation) until study archiving for planning and leading the delivery of interventional, studies to time, quality, budget, company standards and scientific requirements as outlined in the clinical study proposal. This involves generating robust and accelerated delivery plans (with a focus on upper quartile performance) and delivering these to target or stretch thresholds.
Aperçu du poste :
- Ce poste au sein de Global Clinical Delivery (GCD) consiste à devenir responsable de bout en bout, depuis le CSI (Commit to Study Initiation) jusqu’à l’archivage de l’étude, de la planification et de la conduite de la réalisation d’études interventionnelles dans le respect des délais, de la qualité, du budget, des normes de l’entreprise et des exigences scientifiques telles qu’elles sont décrites dans la proposition d’étude clinique. Cela implique de générer des plans de livraison robustes et accélérés (en mettant l’accent sur les performances du quartile supérieur) et de les mener à bien afin d’atteindre les objectifs ou les seuils d’extension.
- Have accountability for the operational delivery of clinical study to time, quality, and budget (e.g., country selection, patient diversity, patient engagement strategy, recruitment plan, etc), driving decision-making at pace and leading study team to achieve overall study deliverables.
- Accountable for assessment and selection of other study vendors under GCD responsibility.
- Ensure compliance with ICH/GCP guidelines, all applicable laws and regulations, and SOPs for assigned studies. understand study contribution to program/submission.
- Accountable for translating asset requirements to the study and appropriate communication with the Asset Lead.
- Balance risk/benefit to make decisions based on clear understanding of impact on the study and project.
- Proactively and effectively identify, oversee, and mitigate study risks.
- Ensure appropriate stakeholder communication, including study status, expectations, risks and issues.
- Preparation of materials for governance and / or financial review cycles.
- Accountable for the study budget.
- Effectively build and lead empowered matrix teams. Not required to line manage staff.
- Implement innovative approaches to study delivery through external facing advances in technology and sciences and encourage others within matrix and line teams to seek innovative perspectives and develop solutions.
- Decision maker for the innovative solutions (eg DCT) to be used at study level.
- Responsible for operational input into protocol and informed consent form development, and other key study documents.
- Lead and conduct investigator meetings and other study related meetings; participate in governance meetings as required.
- Lead quality efforts to ensure protocol compliance and continual inspection readiness for assigned studies.
- Ensure data quality plans and end to end data cleaning is performed instream by the responsible line functions.
- Ensure Clinical Study Report is delivered on time and supports adherence to local regulatory guidance.
- Identify and communicate resource gaps for assigned studies.
- Lead / contribute to ways of working and process improvement initiatives.
Responsabilités :
- Responsable de la réalisation opérationnelle de l’étude clinique dans le respect des délais, de la qualité et du budget (p. ex., sélection des pays, diversité des patients, stratégie d’engagement des patients, plan de recrutement, etc.), en prenant des décisions à un rythme soutenu et en dirigeant le personnel de l’étude afin d’obtenir les résultats escomptés;
- Responsable de l’évaluation et de la sélection des autres fournisseurs de l’étude sous la responsabilité de GCD;
- Assurer la conformité avec les directives CIH/BPC, toutes les lois et réglementations applicables et les PON pour les études affectées. Comprendre la contribution de l’étude au programme/processus de soumission;
- Responsable de la traduction des exigences en matière d’actifs pour l’étude et de la communication appropriée avec le responsable des actifs;
- Faire la balance entre les risques et les avantages afin de prendre des décisions fondées sur une compréhension claire de l’impact sur l’étude et le projet;
- Identifier, superviser et atténuer de manière proactive et efficace les risques liés à l’étude;
- Assurer une communication appropriée avec les parties prenantes, notamment en ce qui concerne l’état d’avancement de l’étude, les attentes, les risques et les problèmes;
- Préparer des documents pour les cycles de gouvernance et/ou d’examen d’ordre financier;
- Rendre compte du budget de l’étude;
- Bâtir et diriger efficacement des équipes matricielles responsabilisées; Il n’est pas nécessaire d’assurer la gestion hiérarchique du personnel;
- Mettre en œuvre des approches novatrices de la réalisation des études grâce à des avancées technologiques et scientifiques externes et encourager les autres membres des équipes matricielles et hiérarchiques à rechercher des perspectives novatrices et à élaborer des solutions;
- Décideur des solutions innovantes (p. ex., DCT) à utiliser au niveau de l’étude;
- Responsable de la contribution opérationnelle à l’élaboration du protocole et du formulaire de consentement éclairé, ainsi que d’autres documents clés de l’étude;
- Diriger et conduire les réunions des chercheurs et d’autres réunions liées à l’étude; participer aux réunions de gouvernance selon les besoins;
- Diriger les efforts en matière de qualité afin d’assurer la conformité au protocole et la préparation continue à l’inspection pour les études assignées;
- Veiller à ce que les plans de qualité des données et le nettoyage des données de bout en bout soient exécutés en cours d’exécution par les fonctions hiérarchiques responsables;
- Veiller à ce que le rapport d’étude clinique soit remis dans les délais et à ce qu’il soit conforme aux directives réglementaires locales;
- Identifier et communiquer les lacunes en matière de ressources pour les études assignées;
- Diriger et contribuer aux méthodes de travail et aux initiatives d’amélioration des processus.
You are an individual with the following:
- Education Requirements (minimum expected):
- Bachelor’s degree: life sciences or related discipline
- The role will require a good understanding of complex clinical development and regulatory processes.
- Job Related Experience (minimum requirements):
- Experience in clinical research: study management, monitoring, data management.
- Strong skills and experience in project management and tools.
- In depth knowledge of GCPs and ICH guidelines.
- Other Job-Related Skills:
- Solid experience working in teams with a broad range of cultures, including matrix team leadership (not required to line manage staff).
- Excellent leadership skills, promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives.
- Excellent understanding of the clinical study, drug development, sample management and other associated process and quality requirements, including ICH/GCP guidelines and SOPs.
- Good project management skills (including scope, budget, timeline, and resource planning and management, and use of associated tools and support where available)
- Able to lead and work within teams and networks across functional and geographical boundaries; leads by example and promotes collaboration, effective communication and leadership in others.
- Able to set and manage priorities, performance targets and project initiatives in a global environment.
- Operational expertise in risk management and contingency planning.
- Applies industry best practices to the design and execution of clinical studies to improve time and cost efficiency.
- Demonstrates conceptual, analytical and strategic thinking.
- Effective at problem solving and conflict resolution.
- Ability to manage change and uncertainty.
- Ability to delegate tasks.
- Demonstrate experience in multicultural settings (to reflect our external customers / clients / health authorities / patients and diverse environments with respect to dynamics of human interaction (including working with remote teams)
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 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 benefits of working at ICON: https://careers.iconplc.com/benefits
At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. 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 through the form below.
https://careers.iconplc.com/reasonable-accommodations
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.
Compétences :
Les exigences en matière de formation professionnelle (minimum attendu) sont les suivantes :
- Baccalauréat en sciences de la vie ou discipline connexe;
- Le poste exige une bonne compréhension des processus complexes de développement clinique et de réglementation.
Expérience liée à l’emploi (exigences minimales) :
- Expérience en recherche clinique : gestion d’études, surveillance, gestion de données;
- Solides compétences et expérience en matière de gestion de projet et d’outils;
- Connaissance approfondie des BPC et des lignes directrices du CIH.
Autres compétences liées au poste :
- Solide expérience du travail en équipe avec un large éventail de cultures, y compris de la direction d’équipes matricielles (il n’est pas nécessaire d’assurer la gestion hiérarchique du personnel);
- Excellentes compétences en matière de leadership, favorisant la motivation et la responsabilisation des autres afin d’atteindre les objectifs individuels, de l’équipe et de l’organisation;
- Excellente compréhension des études cliniques, du développement de médicaments, de la gestion des échantillons et d’autres processus associés ainsi que des exigences de qualité, y compris les lignes directrices CIH/BPC et les procédures opératoires normalisées;
- Bonnes compétences en matière de gestion de projet (y compris la planification et la gestion de l’étendue, du budget, du calendrier et des ressources, ainsi que l’utilisation des outils et du soutien associés, le cas échéant);
- Capacité à diriger et à travailler au sein d’équipes et de réseaux au-delà des frontières fonctionnelles et géographiques; montrer l’exemple et promouvoir la collaboration, une communication efficace et le leadership chez les autres;
- Capacité à fixer et à gérer des priorités, des objectifs de performance et des initiatives de projet dans un environnement international;
- Expertise opérationnelle en matière de gestion des risques et de planification des mesures d’urgence;
- Appliquer les meilleures pratiques de l’industrie à la conception et à l’exécution des études cliniques afin d’améliorer les délais et la rentabilité;
- Faire preuve d’une pensée conceptuelle, analytique et stratégique;
- Assister à la résolution de problèmes et à la résolution de conflit;
- Capacité à gérer le changement et l’incertitude;
- Capacité à déléguer des tâches;
- Démontrer une expérience dans des environnements multiculturels (pour refléter nos clients externes, les autorités sanitaires, les patients et des environnements divers en ce qui concerne la dynamique de l’interaction humaine (y compris le travail avec des équipes à distance).
Impactful work. Meaningful careers. Quality rewards.
At ICON, our employees are our greatest strength. That’s why we are committed to empowering you to live your best life, both inside and outside of work. Whether your ambition is lead a global team, become a deep scientific or technical expert, work in-house with our customers or gain experience in a variety of different ICON functions, we will support you in realising your full potential. See all locations Learn more about Our Culture at ICON
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