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Principal Study Innovation Manager - Home-Based

  1. Canada, United States
2024-109546
  1. Project Management
  2. ICON Strategic Solutions
  3. Remote

About the role

This vacancy has now expired. Please see similar roles below...

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.

 

  • Reporting to the Associate Director or Director within FASTR (Feasibility, Activations and Strategy & Tactics of Recruitment), this role will be responsible for providing support to study teams across key programs, to enable acceleration of sponsor clinical studies
  • Senior Specialist will play a supportive but critical role in the FASTR Team focusing on the delivery of high quality operational, site feasibility and recruitment deliverables, as needed
  • Works in close collaboration with trial management teams and FASTR study start-up, recruitment and feasibility teams to provide key inputs, metrics, and outputs to support study acceleration strategies for program and protocol planning
  • Supports across a range of rare disease areas and FASTR Feasibility / Recruitment Leads

Résumé du poste :

  • Le rôle de ce subordonné du Directeur adjoint ou du Directeur au sein de FASTR (faisabilité, activations, et stratégie et tactiques de recrutement) sera de fournir un soutien aux équipes des études de tous les principaux programmes, afin d’accélérer le déroulement des études cliniques de Vertex.
  • Le (la) spécialiste principal(e) jouera un rôle de soutien essentiel au sein de l’équipe de FASTR axé sur la prestation de services opérationnels de haute qualité, la faisabilité des centres d’étude et les livrables de recrutement, au besoin.
  • Il (elle) travaille en étroite collaboration avec les équipes de gestion des études ainsi que les équipes de démarrage, de recrutement et de faisabilité de FASTR, afin de fournir les principaux intrants, paramètres et extrants pour soutenir les stratégies d’accélération du déroulement des études dans le cadre de la planification des programmes et des protocoles.
  • Il (elle) soutient un large éventail de domaines liés aux maladies rares, la faisabilité FASTR et les pistes de recrutement.

  • Under the supervision of FASTR Director or Associate Director, supports trial optimization and achievement of study milestones by:
    • Information gathering across multiple data sources and platforms to gain a thorough understanding of VX therapeutic areas including standard of care, and patient / site profiles
    • Evaluating the trial landscape though data mining and able to interpret and present findings
    • Supporting enrollment forecasting
    • Effectively communicating with study teams and relevant stakeholders as needed to coordinate and support feasibility activities
    • Providing solutions-oriented, creative thinking to maintain administrative tasks related to supporting seamless feasibility execution
  • Working knowledge of clinical trial conduct and direct study/program operations experience with proven evidence of success
  • Excellent organizational, planning, communication, presentation, and interpersonal skills. A self-starter who motivates, has tact, diplomacy and who has a flexible and positive approach.  Ability to work well in novel situations
  • Complete tasks to deadlines and able to prioritize conflicting demands
  • Demonstrated planning and organizational skills including project management

Principales responsabilités :

  • Sous la supervision du Directeur ou Directeur adjoint de FASTR, il (elle) soutient l’optimisation des études et l’atteinte des principales étapes des études en :
    • recueillant des renseignements à partir de plusieurs sources de données et de plateformes pour acquérir des connaissances approfondies dans les domaines thérapeutiques de Vertex, y compris les normes de soins et les profils des patients/centres d’étude;
    • traçant le paysage des études par l’exploration des données et sa capacité à interpréter et présenter les résultats;
    • soutenant les prévisions concernant le taux d’inscription;
    • communiquant efficacement avec les équipes des études et les intervenants, au besoin, pour coordonner et soutenir les activités de faisabilité;
    • offrant une réflexion créative axée sur les solutions pour faciliter les tâches administratives liées au soutien de l’exécution sans faille de la faisabilité.
  • Des connaissances pratiques sur le déroulement des études cliniques et une expérience directe dans les opérations des études et des programmes avec des preuves de réussite démontrées.
  • D’excellentes compétences en matière d’organisation, de planification, de communication, de présentation et de relations interpersonnelles. Un esprit d’initiative qui motive, du tact, de la diplomatie ainsi qu’une approche flexible et positive. Capacité de bien travailler dans de nouvelles situations.
  • Capacité d’accomplir les tâches dans les délais impartis et d’établir l’ordre des priorités en cas de demandes conflictuelles.
  • Compétences démontrées en matière de planification et d’organisation, y compris la gestion des projets.

  • B.S. in a scientific or allied health field (or equivalent degree) and 3+ years of experience demonstrating thorough understanding of clinical trial conduct and processes and/or 2+ years of feasibility/recruitment
  • Degree preferred or equivalent industry experience
  • Demonstrated administrative and project management abilities in an academic, CRO or sponsor environment.
  • Experience working in multiple rare disease therapeutic areas
  • Experience with data analysis and interpretation
  • Highly proficient with excel
  • Excellent verbal and written communication skills; solutions oriented creative thinking

Compétences minimales :

  • Détenir un diplôme de baccalauréat dans un domaine scientifique ou paramédical (ou un diplôme équivalent) et plus de 3 ans d’expérience démontrant des connaissances approfondies dans la conduite et les processus des études cliniques et/ou plus de 2 ans d’expérience dans la faisabilité/le recrutement.
  • Détenir le diplôme souhaité ou équivalent en expérience dans l’industrie.
  • Capacités démontrées en administration et en gestion de projets dans l’environnement universitaire, d’une organisation de recherche clinique ou d’un commanditaire.
  • Expérience de travail dans plusieurs domaines thérapeutiques pour les maladies rares.
  • Expérience dans l’analyse et l’interprétation de données.
  • Très bonne maîtrise d’Excel.
  • Excellentes compétences en communication verbale et écrite, et pensée créative axée sur les solutions.

 

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.

 

**Actual compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level.**

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