Clinical Project Manager

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.

What you’ll bring to the role:

Essential:

• 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.

Desirable:

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