Clinical Project Manager - oshawa

Job Title: Clinical Project Manager

Remote: Yes

Business Unit: Health

Department: Pharma Patient Support

Job Type: Full-Time.

Length of contract: 1-year contract.

Overview

The CPM is responsible for the planning, implementation, management, and oversight of all operational aspects of local research activities. The scope of such research may include but is not limited to: interventional or non-interventional, clinical or non-clinical, with or without drug / device of focus, Novartis or third party sponsored, primary or secondary data sources, classical clinical study designs, real world evidence, data-diving or implementation science. Although the primary focus of the CPM role is related to local medical research initiatives, CPMs may also be required to support global or regional research initiatives or to consult on data projects led by other functions within Novartis Canada.

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 evident 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 or 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 and 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-part research, manage internal approvals, contract/budget negotiations, milestone tracking and act as liaison between client and the investigator or collaborators.

• If required, provide operational support for Managed Access Programs (MAPs).

• If required, act as local champion representing Novartis Canada at global research-related governance forums.

• Be accountable to perform all duties in accordance with applicable GxP principles and internal/external regulations.

• Fulfill other duties as required

Qualifications:

• B. Sc., M. Sc., B.Pharm., PHD, MD.

• 5 years in clinical research including CRO and/or Sponsor experience (preferred)

• In-depth knowledge of ICH – Good Clinical Practice (GCP) and all relevant regulatory requirements.

• Intermediate Bilingualism – Spoken and Written: English and French

Additional Requirements:

• The candidate must have clinical development experience including monitoring experience, good clinical judgement, good knowledge of the healthcare system, superior inter-personal communication and leadership skills.

• Be result oriented and 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 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 and negotiating with investigators.

Compensation:

• $95,000 - $115,000 per year

Vacancy:

We have one position for this role