SSO Clinical Project Manager
SSO Clinical Project Manager
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Job Description
Band
Level 5Job Description Summary
Location: Montreal or Toronto #LI-HybridNovartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.
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
Job Description
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 youll 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 teams representatives of the patients and communities we serve.
Skills Desired
Budget Management Clinical Trials Clinical Trials Monitoring Conflict Resolution Influencing Without Authority matrix organization Negotiation Negotiation Skills People Management Process Improvement Project Management Project Planning Vendor Management Waterfall ModelRequired Experience:
IC
Employment Type
Full-Time
