Job Description

Working with Us

Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.



Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .

Poste: Gestionnaire d'etudes cliniques

Lieu: Montreal (Saint-Laurent), Quebec

Type d'emploi: Permanent

Chez Bristol Myers Squibb, nous sommes inspire(e)s par une seule vision : transformer la vie des patients grace a la science. Dans les domaines de l'oncologie, de l'hematologie, de l'immunologie et des maladies cardiovasculaire et l'un des pipelines les plus prometteurs de l'industrie, chacun(e) de nos collegues passionne(e)s contribue aux innovations qui entrainent des changements significatifs. Nous apportions une touche humaine a chaque traitement dont nous sommes les pionniers. Notre organisation suit une structure de travail hybride ou les employes peuvent travailler a distance ou au bureau 50% du temps. Rejoignez-nous et faites la difference.

Resume du poste

Assurer la supervision des etudes et la gestion de l'execution (temps, budget, qualite) a l'echelle nationale, du demarrage a la cloture. Le titulaire du poste agit a titre de personne-ressource principale a l'echelle nationalepour les intervenants en interne et en externe.

Responsabilites du role

Assurer la coordination des equipes interfonctionnelles nationales et agir a titre de personne-ressource principale a l'echelle d'un pays de concert avec le gestionnaire de protocole et les autres membres de l'equipe des etudes a l'echelle mondiale. Coordonner, de concert avec d'autres intervenants en interne dans le pays, le processus de faisabilite des centres a l'echelle nationale, y compris la proposition et la validation des objectifs des etudes menees dans le pays. Etablir une strategie de recrutement de patients et d'attenuation des risques pour le pays. Assurer la coordination du recrutement des patients et veiller a ce que les objectifs et les delais d'inscription aux etudes soient respectes a l'echelle nationale. Diriger les efforts de resolution de problemes, y compris la gestion des risques, les imprevus, la resolution des problemes et, le cas echeant, la transmission de ceux-ci aux intervenants appropries. Evaluer et etablir les fournisseurs pendant la periode de demarrage de l'etude (localement). Preparer les reunions avec les investigateurs et y participer. S'assurer que les donnees saisies dans les systemes de gestion des etudes cliniques sont a jour et completes et que le personnel de l'entreprise a l'echelle nationale et des centres de recherche clinique a acces aux systemes eDC et des fournisseurs. Valider les documents de l'etude (c.-a-d. protocole, FCE, materiel destine aux patients). Superviser la preparation des documents propres au pays (par exemple, les amendements globaux specifiques). Preparer le materiel pour les visites de demarrage des etudes aux centres de recherche. S'assurer que les fichiers principaux des etudes sont complets et confirmes aupres de l'equipe locale (a l'echelle nationale et dans les centres). Examiner les rapports de visite de surveillance dans les centres, prendre les mesures necessaires dans les delais prescrits, transmettre les problemes aux intervenants appropries et veiller a la consignation adequate des problemes. Coordonner le verrouillage des bases de donnees et le suivi des requetes. Veiller au respect des echeanciers. Veiller a ce que les etudes menees dans le pays qui lui sont assignees soient pretes pour l'inspection. Soutenir les activites de preinspection et d'inspection par les autorites sanitaires. Coordonner, definir et rediger les mesures correctrices et preventives et assurer la mise en oeuvre des resultats des verifications a l'echelle nationale. Diriger l'examen, la mise en oeuvre et l'achevement des mesures correctrices et preventives. Diriger les reunions des equipes des etudes a l'echelle locale. Examiner et approuver les paiements (en fonction du niveau d'approbation) et gerer les demandes d'indemnisation des patients (le cas echeant). Gerer les relations avec les centres (y compris les questions liees aux organismes de recherche independants). Effectuer a l'occasion des visites d'evaluation prealables a l'etude et des visites de demarrage dans les centres. Effectuer a l'occasion des activites de cloture des centres, y compris apres la fin des etudes. Agir a l'occasion comme personne-ressource pour les centres. Contribuer a l'occasion a la preparation de presentations aux autorites sanitaires locales, aux comites d'ethique et a d'autres instances pertinentes et obtenir leur approbation.
Attentes liees a des taches de cadres superieurs :
Collaborer avec le gestionnaire du protocole, le cadre hierarchique et/ou le chef des operations cliniques pour aider a resoudre des problemes complexes a l'echelle locale et/ou mondiale. Agir comme personne-ressource cle pour ses collegues en fournissant des conseils, en dirigeant la formation et en agissant comme mentor aupres des autres membres de l'equipe au moyen d'un processus de mentorat faisant appel a des presentations officieuses ou officielles.

Qualifications

Baccalaureat ou maitrise en sciences de la vie ou l'equivalent. Gestionnaire d'etudes cliniques : Minimum de 4 ans d'experience connexe dans l'industrie. Gestionnaire principal d'etudes cliniques : Minimum de 6 ans d'experience connexe dans l'industrie. E xperience dans la direction ou en tant que membre actif d'equipes interfonctionnelles, de groupes de travail ou d'initiatives locales et mondiale.

Competences et aptitudes essentielles

Comprehension approfondie des BPC, des lignes directrices de l'ICH et du contexte reglementaire national. Connaissance et comprehension approfondies des processus, de la reglementation et de la methodologie dans le domaine de la recherche clinique. Comprehension de l'environnement clinique et connaissance pratique d'une variete de contextes medicaux et de la gestion des dossiers medicaux. Competences exceptionnelles demontrees en organisation et en planification et capacite de prendre des decisions de facon autonome. Solides competences en matiere d'organisation et de gestion du temps et capacite de gerer efficacement de multiples priorites concurrentes. Aptitude pour la pensee critique et l'analyse des risques. Excellentes aptitudes pour la communication avec une forte orientation client, capacite de gerer les clients internes et externes a tous les echelons de l'organisation. Competences dans l'utilisation de la technologie. Bonne maitrise de la communication orale et ecrite, tant en francais qu'en anglais.

(Avis de non-responsabilite : les responsabilites enumerees ci-dessus ne sont qu'un resume et les autres responsabilites seront des exigences telles qu'attribuees)

Pourquoi postuler

A travers le monde, nous sommes passionne(e)s par la volonte d'avoir un impact sur la vie des patients atteints de maladies graves. Nos valeurs communes de passion, d'innovation, d'urgence, de responsabilite, d'inclusion et d'integrite font ressortir le potentiel le plus eleve de chacun(e) de nos collegues. Bristol Myers Squibb reconnait l'importance de l'equilibre et de la flexibilite dans notre environnement de travail. Nous offrons une grande variete d'avantages, de services et de programmes competitifs qui fournissent a nos employe(e)s les ressources necessaires pour poursuivre leurs objectifs, tant au travail que dans leur vie personnelle. Nous vous invitons a transmettre votre curriculum vitae en ligne et nous nous ferons un plaisir de vous contacter si votre candidature est retenue pour une entrevue dans nos bureaux de Saint-Laurent. Au plaisir de vous rencontrer!

Position: Manager, Clinical Trial

Location: Montreal (Saint-Laurent), Quebec

Job type: Permanent

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science. In oncology, hematology, immunology, and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. Our organization follows a hybrid work structure where employees can work remotely or from the office 50% of the time. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Job Summary

Responsible for study oversight and delivery management (time, budget, quality) at country level from start-up to closure. Serves as the main point of contact at a country level for internal and external stakeholders.

Role responsibilities

Coordinates country cross functional teams and acts as the main point of contact for a Country with the protocol manager and other global study team members. Coordinates with other internal roles in country and site feasibility process, including proposal and validation of country study targets. Develops country level patient recruitment strategy & risk mitigation. Coordinates and ensures country level study enrolment targets and timelines are met. Leads problem solving and resolution efforts including management of risk, contingencies, issue resolution and escalation to the appropriate stakeholder/s. Assessment and set up the of vendors during study start up period (locally). Investigator Meeting participation and preparation. Ensures data entered in Clinical Trial Managements Systems is current and complete and access to eDC and vendor systems is available for the Country and clinical trial site personnel Validation of study related materials (i.e. protocol, ICF, patient material). Responsible for preparing country specific documents (e.g. global country specific amendment. Prepares materials for Site Initiation Visits. Responsible for verifying and confirming with local team eTMF completeness (Country and Site level). Reviews Site Monitoring visit reports, takes action within the timelines specified and escalates issues and ensures appropriate documentation of issues. Coordination of database locks and query follow up. Ensures timelines are met. Ensure inspection readiness of assigned trials within country. Provide support to Health Authority inspection and preinspection activities. Coordinates, develops and writes the Corrective Actions / Preventive Actions (CAPA) and ensures implementation for Country audit level findings. Drives CAPA review, implementation and completion. Lead study team meetings locally o Reviewing and approving payments (based on GOA) and manage patient compensation claims (if applicable). Management of Site relationships (includes CRO related issues). May conduct Pre-Study Evaluation Visits (PSEVs) and Site Initiation Visits (SIVs). May perform site closure activities, including post-close out. May act as point of contact for Sites. May support preparing submissions to and obtaining approval from local Health Authorities, Ethics Committees and other relevant instances.

Senior Level Expectations:Engage with Global Trial Manager, line management and/or Head of Clinical Operations to assist in the resolution of complex issues both locally and/or globally. Serve as a key resource for colleagues, by providing guidance, leading training and mentoring to other team members through a mentoring process using informal and/or formal presentations. May be assigned as a Lead CTM for a study locally and as determined by leadership.

Qualifications

Bachelor's degree required preferably within life sciences or equivalent. Clinical Trial Manager: Minimum of 4 years' industry related experience. Senior Clinical Trial Manager: At least 6 years of industry related experience. Experience in leading or participating as an active member of cross functional teams, task forces, or local and global initiatives.

Essential Skills and Abilities

Thorough understanding of GCP, ICH Guidelines and Country regulatory environment. In depth knowledge and understanding of clinical research processes, regulations and methodology. Understands clinical landscape with practical knowledge of a variety of medical settings and medical records management. Demonstrated organizational and planning skills and independent decision-making ability. Strong organization and time management skills and ability to effectively manage multiple competing priorities. Ability of critical thinking and risk analysis. Strong communication skills with a strong customer focus, able to manage both internal and external clients at all organizational levels. Skilled in the use of technology. Good verbal and written communication skills (both in English and local language).

(Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)

Why You Should Apply

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion, and integrity bring out the highest potential of each of our colleagues. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

#LI-Hybrid

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as Transforming patients' lives through science(TM) , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:




Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.




BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.




BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.




BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.



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