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 :

Data Monitoring and Safety Board (DMSB) Setup :

Coordination with Contract Research Organizations (CROs) :

Site Management & Monitoring :

Logistics & Material Management :

Regulatory Compliance & Documentation :

Cross-Functional Collaboration :

Strategic Leadership & Decision Making :

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 :

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