Summary

Location: Montreal/Toronto, #LI-Onsite
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 looking for a Clinical Project Manager (CPM) to work within the Health Research & Data (HR&D) team, co-leading our efforts to address the local data gaps and implementation struggles identified within the Canadian healthcare landscape, by developing and implementing effective research activities within our country.

This role will work directly with the Health Research & Data (HR&D) team and reports to the Director, HR&D.

About the Role

Key responsibilities:

• Serve as a strategic partner to the cross-functional team, bringing technical and operational expertise in the development of local (or regional/global) research initiatives as part of an integrated evidence generation plan.
• Collaborate in the process of innovative study design, in alignment with the integrated evidence generation plan, and incorporating patient and clinician recommendations;
• Select and manage External Service Providers (ESPs) and third-party research collaborators, if required;
• Direct study start-up activities (including, but not limited to: protocol development, Case Report Form (CRF) development, database set-up, Informed Consent development or review, study site identification and selection activities, regulatory documents collection, Drug Supply Management (DSM) activities, training of research associates and development of relevant study plans);
• Maintain operational oversight throughout the recruitment and maintenance phases of the study (including, but not limited to: recruitment, monitoring, safety reconciliation, data management, statistical planning, drug supply management, study operations, milestone tracking and budget management);
• Direct study close-out activities (including, but not limited to: close-out monitoring, database lock, drug reconciliation, safety reconciliation, data analysis, study report, publications, data dissemination and archiving);
• Manage and hold overall accountability for study budget planning, budget and drug forecasting and ongoing reconciliation;
• Manage and hold overall accountability for study timelines, milestones, key performance indicators (KPIs) and audit-readiness;
• Manage contract and budget negotiations with investigators, institutions, ESPs and other third-parties;
• In the context of third-party research, manage internal approvals, contract/budget negotiations, milestone tracking and act as liaison between Novartis and the investigator or collaborators.

• Academic background: B.Sc., M.Sc., B.Pharm., PhD, MD.
• Minimum of 5 years of experience in clinical research

• The candidate must have clinical development experience including monitoring experience, good clinical judgment, good knowledge of the healthcare system, superior inter-personal, communication and leadership skills, be results oriented and be a team player.
• In-depth knowledge of ICH - Good Clinical Practice (GCP) and all relevant regulatory requirements. Experience in running clinical activities according to ICH-GCP as well as Canadian regulatory clinical trial regulations and IMC guidelines.
• Problem solving skills required to develop strategies and contingency plans to manage studies within limited budget, resources and deadlines in a highly competitive environment.
• Flexibility: able to shift priorities quickly and adapt to changes in the environment.
• Working knowledge of finance: Developing budgets for trials, negotiating with investigators.

• Intermediate Bilingualism - Oral and Written: English and French (Quebec only).