Clinical Project Manager

1 week ago

Montréal, Canada Novartis Full time

394129BR

**Clinical Project Manager - Site & Study Operations(SSO)**:
Canada

**About the role**

Location: Montreal, #LI-Hybrid
About the role:
We are looking for an innovative, experienced, and agile project manager who wants to have an impact on day-to-day planning, executing, and reporting of Global Drug Development (GDD) studies and make a difference in joining us to reimagining medicine. As a SSO (Study Start-up Organization) Clinical Project Manager you will be the single point of contact and study team lead with the country/cluster/hub for assigned studies. You are accountable for the execution and reporting of assigned GDD studies and responsible for creating and driving strategic integrated projects, collaborating in a dynamic environment with internal and external stakeholders.
The role reports into the Novartis Canada Portfolio Team Lead and will proactively work on globally assigned studies within the Country/cluster/hub.
Key Responsibilities:

- Supports SSO 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

**Commitment to Diversity & Inclusion**:

- Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve._

**Role Requirements**

Essential Requirements:

- 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)
- Communicates effectively in a local/global matrixed environment

Desirable Requirements:

- Bilingual: English and French an asset

Novartis

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**

GCO GDD

**Work Location**

Montreal

**Company/Legal Entity**

Novartis Pharma Canada

**Functional Area**

Research & Development

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**

No

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