Fsp - Clinical Project Manager

2 weeks ago

Montréal, Canada Allphase Clinical Research Inc. Full time

**Job Title**: FSP - Clinical Project Manager
**Date**: May 17, 2024
**Location**: Montreal, QC
**Remote**: Yes
**Business Unit**: Health
**Division**: Pharma - CRO
- Do you want the opportunity to be embedded within big pharma?
- Do you want to drive the strategy, planning and implementation of local research to address healthcare system gaps and ensure the best possible treatments for patients in Canada?
- If so, we would love to hear from YOU

**Job Summary**:
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, client 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 the client's Canadian operation.
**Your responsibilities include, but are not limited to**: - 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 client and the investigator or collaborators;
- If required, provide operational support for Managed Access Programs (MAPs);
- Be accountable to perform all duties in accordance with applicable GxP principles and internal/external regulations.

**Qualifications**: - Education: B.Sc., M.Sc., B.Pharm., PhD, MD;
- 5+ years’ experience in clinical research, data science, implementation science or similar field

**Key Competencies**:

- 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.
- Languages: Intermediate Bilingualism - Oral and written English and French.

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