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Clinical Operations Manager Lead for FDA Pivotal Trials
6 days ago
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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