Gestionnaire, d’études cliniques / Manager, Clinical Trial

at  BristolMyers Squibb

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 rich in diversity. 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.

QUALIFICATIONS ET EXPÉRIENCE

• Baccalauréat en sciences de la vie ou l’équivalent
• Gestionnaire d’études cliniques : Minimum de 4 ans d’expérience connexe dans l’industrie
• Gestionnaire principal d’études cliniques : Minimum de 6 ans d’expérience connexe dans l’industrie
• Expérience dans la direction ou en tant que membre actif d’équipes interfonctionnelles, de groupes de travail ou d’initiatives locales et mondiales
• Compréhension approfondie des BPC, des lignes directrices de l’ICH et du contexte réglementaire national.
• Connaissance et compréhension approfondies des processus, de la réglementation et de la méthodologie dans le domaine de la recherche clinique
• Compréhension de l’environnement clinique et connaissance pratique d’une variété de contextes médicaux et de la gestion des dossiers médicaux
• Compétences exceptionnelles démontrées en organisation et en planification et capacité de prendre des décisions de façon autonome
• Solides compétences en matière d’organisation et de gestion du temps et capacité de gérer efficacement de multiples priorités concurrentes
• Aptitude pour la pensée critique et l’analyse des risques
• Excellentes aptitudes pour la communication avec une forte orientation client, capacité de gérer les clients internes et externes à tous les échelons de l’organisation
• Compétences dans l’utilisation de la technologie
• Bonnes aptitudes en communication orale et écrite, tant en anglais que dans la langue locale
• Suite Microsoft
• Système de gestion des études cliniques (CTMS)
• Systèmes de saisie électronique de données (eDC)
• Fichiers principaux des études (eTMF)

POSITION SUMMARY

The successful candidate will partner with Brand and Sales leadership to create the vision and strategy for field reporting and analytics in alignment with leadership priorities and business stakeholder requirements.

QUALIFICATIONS & EXPERIENCE

• 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
• 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 French)
• Suite Microsoft
• Système de gestion des études cliniques (CTMS)
• Systèmes de saisie électronique de données (eDC)
• Fichiers principaux des études (eTMF)

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.
We invite you to forward your resume online and we will be happy to contact you if your candidacy is selected for an interview in our offices in Ville Saint-Laurent. Looking forward to meeting you!
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.

• 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 pre-inspection 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
• Reviewing and approving payments (based on GOA) and manage patient compensation claims (if applicable)
• Management of Site relationships (includes CRO related issues)
• May support or conduct Pre-Study Evaluation Visits (PSEVs) and Site Initiation Visits (SIVs), as needed
• May support or perform site closure activities, including post-close out, as needed
• 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