Clinical Trial Manager

**Job Summary**
VIDC is seeking an experienced and motivated Clinical Trial Manager (CTM) to oversee the planning, implementation, and coordination of clinical trials in a dynamic medical and research environment. The CTM will work closely with the Medical Director, Research Manager, and multidisciplinary teams to ensure all trials are conducted in accordance with GCP guidelines, ethical standards, and regulatory requirements. This position is essential to maintaining the integrity, quality, and efficiency of ongoing and upcoming research studies, with a focus on HIV, HCV, and related conditions.

**Key Responsibilities**:
Clinical Trial Oversight
- Manage the full lifecycle of clinical trials, including planning, startup, execution, monitoring, and close-out.
- Supervise and mentor clinical research staff (including CRCs), ensuring protocol compliance, task delegation, and professional development.
- Oversee IRB and ethics committee submissions, renewals, and amendments with strong overall knowledge of ethical and IRB processing.
- Ensure accurate maintenance of trial documentation, including screening logs, informed consent forms, protocol deviations, and adverse event reports.
- Ensure all clinical activities are aligned with study protocols, timelines, budgets, and applicable regulations (ICH-GCP, Health Canada, FDA, etc.).
- Serve as the main point of contact between sponsors, CROs, and internal teams for clinical operations.
- Coordinate and prepare for monitoring visits, audits, and inspections, ensuring audit readiness.
- Supervise and support staff in data entry, CRF/DCF completion, and database management to maintain data integrity.
- Provide oversight of biological sample collection, handling, storage, and shipping in coordination with lab teams.
- Facilitate cross-functional collaboration among research, clinical, data, and administrative teams.
- Report to senior leadership on study status, risks, timelines, and recommendations.

Required Knowledge and Abilities:

- Comprehensive knowledge of clinical research operations and trial workflow.
- Demonstrated ability to manage complex projects with multiple stakeholders.
- Strong leadership skills and experience supervising cross-functional teams.
- In-depth understanding of ethical conduct in research, including experience with IRB submissions and regulatory documentation.
- Experience working with marginalized and vulnerable populations in a culturally safe and competent manner.
- Excellent organizational, time-management, and problem-solving abilities.
- Strong communication skills (verbal and written), with the ability to liaise professionally with sponsors, staff, and study participants.
- Familiarity with electronic data capture (EDC) systems and clinical trial management systems (CTMS).
- Commitment to upholding research integrity and compliance.

Educational/Professional Requirements:

- Bachelor's degree in Life Sciences (e.g., Biology, Chemistry), Health Sciences (e.g., Public Health, Clinical Research), or other related scientific fields.
- Minimum 3-5 years of experience in clinical research, including at least 2 years in a coordination or management role.
- Valid certifications in GCP and IATA; phlebotomy certification is considered an asset.
- Prior experience in participant recruitment, regulatory submissions, and trial oversight is essential.

**Job Types**: Full-time, Permanent

Pay: $55,000.00-$65,000.00 per year

**Benefits**:

- Dental care
- Paid time off

Ability to commute/relocate:

- Vancouver, BC V6Z 2C7: reliably commute or plan to relocate before starting work (preferred)

**Experience**:

- clinical research: 3 years (preferred)

**Language**:

- French (preferred)

**Location**:

- Vancouver, BC V6Z 2C7 (preferred)

Work Location: In person