Medical Device Clinical Trials Manager

1 week ago

Calgary, Alberta, Canada Fluid Biomed Inc. Full time

Job Summary

We are seeking an experienced Clinical Operations Specialist to lead the creation, execution, and management of multi-site international clinical trials for our novel implantable medical device. The successful candidate will have significant experience in FDA pivotal clinical trials, institutional applications, Data Monitoring and Safety Boards (DMSB), site monitoring, and clinical trial logistics.

Responsibilities:

  • FDA Pivotal Clinical Trial Management:
    • Develop and execute comprehensive plans for FDA pivotal clinical trials, ensuring compliance with FDA regulations, guidance documents, and other relevant regulatory requirements.
    • Oversee the creation of regulatory submissions, including Investigational New Device (IDE) applications, safety reports, and clinical trial data packages required for pivotal trials.
    • Collaborate with key stakeholders to ensure clinical trial design is scientifically robust and compliant with regulatory expectations.
  • Clinical Trial Design & Planning:
    • Lead the development of clinical trial protocols, study charters, and operational plans for multi-site international trials, ensuring they are aligned with both FDA and local regulatory requirements.
    • Develop and manage institutional applications for trial approvals, facilitating timely and efficient submission to regulatory bodies, ethics committees, and Institutional Review Boards (IRBs).
  • Data Monitoring and Safety Board (DMSB) Setup:
    • Establish and charter Data Monitoring and Safety Boards (DMSBs), ensuring the appropriate selection of independent members and facilitating DMSB meetings and safety monitoring.
    • Ensure DMSB protocols are adhered to and interim safety data are reviewed regularly, addressing any potential risks or concerns to patient safety.
  • Cross-Functional Collaboration:
    • Work closely with the Engineering, Regulatory, Quality, and Operations teams to ensure smooth execution and delivery of pivotal trials.
    • Act as a subject matter expert on FDA regulations and guidance for pivotal clinical trials and provide guidance to cross-functional teams.
  • Strategic Leadership & Decision Making:
    • Drive strategic planning for pivotal clinical trials, including the development of study timelines, budgets, and resource allocation.
    • Make data-driven decisions to ensure that clinical trial progress aligns with company objectives and FDA submission requirements.

Qualifications:

Education: Bachelor's degree or equivalent education, with specific experience in clinical trial design and execution.

Experience: 3+ years of experience in clinical trial operations, with specific experience leading FDA pivotal clinical trials.

Certification: Clinical Research Coordinator (CRC), Clinical Research Associate (CRA), or other relevant certifications preferred.

Salary: $80,000 - $110,000 per year, depending on experience.

This role will be located physically on-site in Calgary, Alberta, and candidates must be legally entitled to work full-time in Canada.

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