Key responsibilities:

• 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) an asset
• Experience in various therapeutic areas including Cardiovascular, Renal & Metabolism, Immunology, Oncology and Neuroscience.

At Novartis Canada, we are determined to be a valued partner and advocate, with a deep understanding of patient needs along the entire care journey – from drug development, to diagnosis, to access and beyond. Part of the way we are doing this is by leveraging data, technology, and partnerships.

Research & Development: we focus on four core therapeutic areas: Cardiovascular, Renal & Metabolic, Immunology, Neuroscience and Oncology. We also develop and deliver treatments through other promoted and established brands, which today are helping millions of patients. Over the last three years, our average annual research and development investment in Canada was over $30 million, and we conduct clinical trial research in every region throughout Canada.

Commitment to Diversity and Inclusion: Novartis is committed to building outstanding, inclusive work environment and diverse team’s representatives of the patients and communities we serve.