Clinical Affairs Manager

5 months ago

Vancouver, Canada Response Biomedical Full time

**Who we are**:
Response Biomedical Corp. has been transforming acute care diagnostic testing, with a focus on improving patient outcomes for over 20 years. Response Biomedical fosters a values-based culture, committed to making diversity and inclusion our way of doing business. We believe the people we work with, including our partners, medical teams, and employees are the cornerstone of our success.

**What we do**:
Response is a global leader in acute care testing and our RAMP platform is commercialized worldwide with tests for life-threatening conditions such as cardiovascular disease, infectious disease, sepsis, and pregnancy, We understand the stresses associated with rapid, accurate diagnosis when every minute counts, and are committed to supplying high quality products and excellence in service to healthcare professionals to help save lives. We do this by providing lab-quality results within minutes that medical teams can trust while reducing the total cost of care.

**Who we are looking for**:
We are currently seeking a dynamic Clinical Affairs Manager with exceptional communication skills and solid expertise in IVD technical clinical research operations. This role will be pivotal in spearheading the planning, coordination, and execution of our clinical performance studies.

**Key Responsibilities**:

- Lead the day-to-day operations of multiple IVD clinical performance studies.
- Develop and manage clinical study plans and budgets, ensuring efficiency and adherence to timelines.
- Design and develop the clinical strategy for new products and existing products entering new jurisdictions and ensure compliance to applicable standards
- Coordinate the preparation of Clinical Investigational Plans/ITAs and associated study materials (protocols, CRFs, etc..).
- Ensure smooth study initiation through effective site qualification procedures and development.
- Manage clinical research associates and provide mentorship, leadership, direction and performance reviews
- Conduct routine and ad hoc meetings, providing updates to cross-functional teams and senior leadership
- Manage medical monitoring processes, core labs, and other study vendors, liaising with study committees as necessary.
- Assist in the preparation of Clinical Reports for regulatory submissions and post market surveillance activities
- Cultivate and maintain working relationships with CROs, clinical support staff, site investigators, and stakeholders.
- Support the establishment of procedures and work instructions for efficient study conduct and compliance.
- Coordinate the preparation of clinical study reports and summaries for internal review and potential publication.
- Oversee the maintenance of all trial master files at company and investigational sites.
- Prepare for audits, inspections and respond to findings from regulatory authorities related to Clinical Affairs
- Act as a core team member on project teams, providing clinical trial guidance and strategic planning.
- Participate in and review risk management activities and documents.
- Support global commercialization activities in alignment with regulatory and quality requirements.
- Perform other duties as required or assigned.

**Education, Work Experience, Knowledge, and Skills**:
**Formal Education**:

- Bachelor's Degree in Science, Health Science or related degree
- Masters / PhD or Clinical Trial Management Certification would be an asset
- Clinical Research Associate Certification (CCRA and/or CCRP) an asset

**Work Experience**:

- Minimum of 10 years of experience in diagnostics, life sciences, or medical devices, with at least 5 years in clinical research or clinical affairs
- Previous experience with GCPs and internal audits.
- Previous experience leading clinical trials in the US/Canada would be an asset

**Knowledge and Skills**:

- Demonstrated ability to manage and execute clinical studies with IVDs using best practices and compliance norms.
- Proficiency in supervising CRAs and Monitors and collaborating successfully in cross-functional teams.
- Detailed knowledge of GCPs, ISO 14155, EN 13612, IDEs, 510(k)s, IVDD/IVDR, ISO 13485, and relevant international standards.
- Working knowledge of medical device risk management standards, specifically ISO 14971.
- Strong understanding of IVD products, immunoassays, IVD instruments and software, and clinical lab materials.
- Excellent communication, organizational, analytical, and presentation skills.
- Ability to provide solutions to technical challenges and maintain a big-picture perspective.
- Strong leadership skills with a commitment to quality and integrity.
- Availability for flexible schedules and international travel as needed.
- _We regret that relocation will not be provided._
- We're committed to a diverse and inclusive workplace. We welcome applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. All employment decisions are based

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