Clinical Operations Manager Lead for FDA Pivotal Trials

6 days ago


Calgary, Alberta, Canada Fluid Biomed Inc. Full time

Company Overview: Fluid Biomed Inc. is an innovative medical device startup focused on developing cutting-edge neurovascular stents to treat brain aneurysms and enhance patient outcomes worldwide.

Job Summary: We are seeking a highly skilled Clinical Operations Manager to lead the creation, execution, and management of multi-site international clinical trials, including pivotal studies required for FDA approval.

Key Responsibilities:

  • Lead the planning, execution, and management of 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.
  • Develop and manage the clinical trial strategy, including study design, patient recruitment, and endpoints, in alignment with FDA requirements for successful submission and approval.
  • Ensure proper implementation of pivotal trial protocols, including adherence to specific FDA regulatory requirements for patient safety, data integrity, and statistical analysis.

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.
  • Collaborate with key stakeholders (e.g., medical, regulatory, quality assurance) to ensure clinical trial design is scientifically robust and compliant with regulatory expectations.
  • 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:

  • Lead the creation and chartering of Data Monitoring and Safety Boards (DMSB), 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.

Coordination with Contract Research Organizations (CROs):

  • Act as the primary liaison between the internal clinical operations team and external CROs, managing timelines, deliverables, and expectations for pivotal clinical trials.
  • Ensure CROs comply with FDA guidelines, Good Clinical Practice (GCP), and the study protocol.
  • Monitor and review CRO performance, ensuring all milestones, including patient enrollment, data collection, and monitoring, are completed on time and within budget.

Site Management & Monitoring:

  • Oversee the selection, initiation, and monitoring of clinical trial sites for multi-site international trials, ensuring sites are compliant with FDA requirements and GCP.
  • Develop and execute comprehensive site monitoring plans, ensuring that clinical sites are trained on protocol adherence, FDA regulatory compliance, and patient safety.
  • Perform site visits (or manage CRO site visits) to monitor progress, data quality, and compliance, and resolve any issues to maintain timelines and data integrity.

Logistics & Material Management:

  • Coordinate the timely delivery of study materials, including investigational products, medical devices, and trial-related documentation, to international sites.
  • Ensure that all clinical trial materials and shipments comply with FDA and local regulatory requirements for import/export, patient safety, and product quality.

Regulatory Compliance & Documentation:

  • Ensure clinical trials are conducted in full compliance with FDA regulations, ICH-GCP guidelines, and other applicable regulations.
  • Oversee the preparation of essential regulatory documents such as clinical trial agreements (CTAs), informed consent forms (ICFs), IND submissions, safety reports, and clinical study reports (CSRs).
  • Track and report study progress to key stakeholders, ensuring timely reporting of any significant findings, adverse events, or safety concerns to regulatory authorities.

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.
  • Manage risk assessments, identify potential trial issues, and implement corrective actions to keep studies on track.

Compensation Package: The estimated annual salary range for this position is $120,000-$160,000 CAD, depending on experience.

Location: This role will be located physically on-site in Calgary, Alberta, Canada.



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