This is a full-time opportunity to join the technical team of an early-stage company to support the development and commercialization of a novel implantable medical device. Fluid Biomed is an innovative medical device startup focused on developing a cutting-edge neurovascular stent to treat brain aneurysms and enhance patient outcomes worldwide.
We are seeking a highly skilled and experienced Clinical Operations Manager to lead the creation, execution, and management of multi-site international clinical trials, including pivotal studies required for FDA approval. This individual will be responsible for ensuring the successful design, implementation, and oversight of pivotal clinical trials, managing cross-functional teams, and collaborating with Contract Research Organizations (CROs), clinical sites, and regulatory bodies. The ideal candidate will have significant experience in FDA pivotal clinical trials, institutional applications, Data Monitoring and Safety Boards (DMSB), site monitoring, and clinical trial logistics.
Key Responsibilities :
FDA Pivotal Clinical Trial Management :
- Lead the planning, execution, and management of FDA pivotal clinical trials, ensuring compliance with FDA regulations, guidance documents, and other relevant regulatory requirements (e.g., 21 CFR Part 312, ICH E6).
- 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.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.
Skills :
o Strong experience in managing FDA pivotal trials, including knowledge of FDA regulations (21 CFR Part 312) and submission processes.o In-depth understanding of clinical trial design, execution, and regulatory compliance, especially in the context of FDA submissions.o Proven ability to manage multi-site international trials, including site selection, monitoring, and logistics coordination.o Experience with DMSB setup and oversight, including safety data monitoring and risk management.o Familiarity with clinical trial management software and data management systems.o Strong project management, communication, and leadership skills.o Knowledge of global regulatory frameworks beyond the FDA (e.g., EMA, PMDA).Role will be located physically on-site in Calgary, Alberta and candidates must be legally entitled to work full-time in Canada.
