Job Description

Overview
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 as a Clinical Research Associate.
ICON plc est une organisation de premier plan specialisee en intelligence en sante et en recherche clinique. Nous sommes fiers de favoriser un environnement inclusif qui stimule l'innovation et l'excellence. Nous vous invitons a vous joindre a nous dans notre mission visant a faconner l'avenir du developpement clinique en tant qu'Associe(e) de recherche clinique.
Responsibilities
What you will be doing:

• Oversee multiple oncology trials, ensuring high-quality execution

• Provide leadership and mentorship to junior flex team members

• Act as Lead SM, training and guiding other Site Managers on study protocols

• Develop essential study start-up documents, including SIV agendas

• Represent Site Managers and Lead Trial Managers (LTMs) in key meetings

• Ensure the SM perspective is reflected in study documents like Monitoring Guidelines

• Review reports (SQV, SMV, SCV) for sites assigned to other SMs within the same trial

• Support country budget development and contract negotiations in collaboration with CCS colleagues

• Assist with ASV activities and ensure alignment with study objectives

• Maintain compliance with Metrics/KPIs as outlined in the Quality Oversight Plan (QOP)

Ce que vous ferez :

• Superviser plusieurs essais en oncologie, en veillant a leur execution de haute qualite
• Fournir du leadership et du mentorat aux membres juniors de l'equipe flexible
• Agir en tant que Gestionnaire de Site principal (Lead SM), en formant et guidant les autres Gestionnaires de Site sur les protocoles d'etude
• Developper des documents essentiels pour le demarrage des etudes, y compris les ordres du jour des visites de mise en place des sites (SIV)
• Representer les Gestionnaires de Site et les Gestionnaires d'Essai Principaux (LTMs) lors de reunions cles
• S'assurer que la perspective des Gestionnaires de Site est bien refletee dans les documents d'etude, comme les Lignes directrices de Surveillance
• Reviser les rapports (SQV, SMV, SCV) pour les sites attribues a d'autres Gestionnaires de Site dans le meme essai
• Soutenir le developpement des budgets pays et les negociations contractuelles en collaboration avec les collegues du CCS
• Assister aux activites ASV et veiller a l'alignement avec les objectifs de l'etude
• Maintenir la conformite aux indicateurs de performance (Metrics/KPIs) conformement au Plan de Surveillance de la Qualite (QOP)

Qualifications
You Are:

• Remote position located in Montreal
• Bilingual - Proficient in both written and spoken French and English.
• Minimum of a B.Sc., R.N., or equivalent degree, preferably in Biological Sciences
• At least 2 years of experience monitoring clinical trials in the pharmaceutical industry
• Experience in multiple therapeutic areas is an asset, particularly in oncology (Hematology, Prostate Cancer, Lung Cancer, Early Development - Phase 1)
• Knowledge of risk-based/analytical monitoring approaches is an asset
• Proficiency in clinical trial systems such as CTMS, EDC, TMF, IWRS, and safety reporting tools
• Ability to actively drive patient recruitment strategies at assigned sites
• Strong collaboration with investigators and site staff to meet study timelines
• Effective communication and influencing skills to manage study sites effectively, both remotely and in-person
• Ability to work independently while being a strong collaborator
• In-depth understanding of Good Clinical Practice (GCP), ICH guidelines, and local regulatory requirements
• Up to 50% regional travel required

Vous etes :

• Poste en teletravail base a Montreal
• Bilingue - Maitrise du francais et de l'anglais, a l'ecrit comme a l'oral
• Titulaire d'un B.Sc., d'un diplome d'infirmier(ere) autorise(e) (R.N.), ou d'un diplome equivalent, de preference en sciences biologiques
• Minimum de 2 ans d'experience en surveillance d'essais cliniques dans l'industrie pharmaceutique
• Experience dans plusieurs aires therapeutiques, un atout - particulierement en oncologie (hematologie, cancer de la prostate, cancer du poumon, developpement precoce - phase 1)
• Connaissance des approches de surveillance analytique/basee sur les risques, un atout
• Maitrise des systemes d'essais cliniques : CTMS, EDC, TMF, IWRS et outils de declaration de securite
• Capacite a piloter activement les strategies de recrutement de patients sur les sites assignes
• Forte collaboration avec les investigateurs et le personnel des sites pour respecter les echeanciers de l'etude
• Excellentes competences en communication et en influence pour gerer efficacement les sites d'etude, a distance et en presentiel
• Capacite a travailler de maniere autonome tout en favorisant une collaboration efficace
• Connaissance approfondie des Bonnes Pratiques Cliniques (BPC), des lignes directrices ICH et des exigences reglementaires locales
• Disponibilite pour voyager jusqu'a 50 % dans la region

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, 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, colour, 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.