Clinical Project Manager

2 weeks ago

Quebec Province, Canada Next Level Impacts Full time

**Overview**:
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**Job Summary**:
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**The Clinical Project Manager is responsible for the orchestration and completion of clinical trials involving in vitro diagnostic (IVD) assays. Operating within pre-defined budgetary, scope, and timeline constraints, the role generally focuses on one area such as Molecular, Immunoassay, or Blood Chemistry. Key tasks involve coordinating multiple functional teams, including project management, clinical monitoring, data management, and quality assurance, to ensure the project is conducted, controlled, and concluded in line with best practices, including Project Management discipline and Good Clinical Practice (GCP).**
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**Key Responsibilities**:
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- **Lead and supervise a small team of clinical operation professionals in compliance with GCP and other regulatory guidelines.**:

- **Manage project timelines, resources, and budgets effectively.**:

- **Oversee the selection of clinical trial sites, Contract Research Organizations (CROs), and the development of contracts.**:

- **Prepare clinical protocol/amendments, case report forms, and facilitate Institutional Review Board (IRB) submissions.**:

- **Monitor and review clinical trial data; contribute to reports and regulatory submissions.**:

- **Anticipate risks and track project progress; stay updated on changes in regulatory guidelines.**:

- **Participate in special organizational projects and initiatives.**

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**Qualifications**:
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- **Bachelor’s degree in biological sciences; MS degree preferred.**:

- **Minimum 5 years of experience in Clinical Operations, Medical Affairs, R&D, or Regulatory Affairs.**:

- **Minimum 3 years of experience in managing clinical trials; international trial experience is an asset.**:

- **Experience in in vitro diagnostics is preferred; PMP certification an asset.**

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**Requirements**:
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- **Travel: Up to 30% required.**:

- **Physical and Mental: Stamina to meet the demanding nature of the role, including long periods at a computer.**:

- **Other: Willingness to handle biohazardous materials with appropriate safety measures in place.**

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**By joining our team, you will be part of an organization that is committed to innovation, teamwork, and making a tangible impact in the medical diagnostic field.**:

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