Sso Clinical Project Manager

**Summary**:
Location: Montreal or Toronto, #LI-Hybrid

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.

About the role:
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 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

**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.

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

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.