Regional Clinical Project Manager (SSO)

Summary

Location: Montreal/ Toronto, #LI-Hybrid
Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

About the role:

We are seeking an innovative, experienced, and agile project manager who is driven by accelerating the planification, execution, and reporting of globally run clinical trials and who is motivated in making a difference in reimagining medicine.

As a Regional (LaCan - Latin America and Canada) Clinical Project Manager you will be the single point of contact to Global study team regarding your LaCan Cluster assigned trials. Accountable for the execution and reporting of assigned trials, you will create and drive project strategy and collaborate in a dynamic environment with internal and external stakeholders.

This role will work directly with the global study teams and the local clinical research teams and reports to the Portfolio Team Lead

About the Role

Key responsibities:

• Supports Study Start-up Manager in the development of country/cluster/hub study execution plans and timeline commitments
• Participates in the recruitment sub-team and supports the development of innovative solutions for site and patient participation to ensure the delivery of assigned studies on time
• Proactively identifies risk and opportunities for the assigned studies within the country/cluster/hub and develops respective mitigation plans
• Drives the conduct of the study, (tracks status, maintains relevant reporting systems, oversees forecasts, progress, and mitigation plans), to ensure all study operational aspects are on track
• Oversees local study team activities to achieve study timelines and quality execution, (proposing and implementing corrective actions where appropriate), according to Novartis standards and relevant regulations
• Conducts or coordinates training, as needed, for CRAs to support site readiness to recruit and study execution ensuring adherence to clinical data standards, prevailing legislation, GCP, Ethical Committee and SOP requirements
• Maintains oversight of country/cluster/hub level data management activities, including timely understanding of screen failure reasons and discontinuation rates, review of patient profiles, and proactively identifies data entry issues (on quality and timing) to mitigate queries, proactively identifies query resolution issues
• Promotes a compliance culture advocating the adherence to highest standards and ethical integrity, ensuring human subject protection and reliability of trial results at all times

What you'll bring to the role:

Essential:

• A degree in scientific or health discipline required and advanced degree with clinical trial experience and/or project management, is preferable
• Minimum 5 years' experience in clinical research in a role that oversees (project management) and/or with monitoring clinical trials
• Capable of leading in a matrix environment, without direct reports and working cross-border managing study in various countries
• Strong project management capabilities with demonstrated ability to problem solve and mediate complex issues
• Demonstrated negotiation and conflict resolution skills both internal and external (site relationships)

Desirable:

• Bilingual: English and French - Spanish is an asset
• Experience in various therapeutic areas including Cardiovascular, Renal & Metabolism, Immunology, Oncology and Neuroscience

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

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Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Division
Development

Business Unit
Innovative Medicines

Location
Canada

Site
Montreal

Company / Legal Entity
CA04 (FCRS = CA004) NOVARTIS PHARMA CANADA INC.

Alternative Location 1
Toronto, Canada

Functional Area
Research & Development

Job Type
Full time

Employment Type
Regular

Shift Work
No