Lead clinical research compliance and computerized system validation at SickKids in a hybrid, full time two-year contract position. Apply regulatory expertise across clinical technologies.

The Clinical Research Regulatory Compliance Lead supports SickKids Clinical Research Operations and its Precision Child Health priorities. This role guides regulated clinical trials, technology implementation, validation, and standardized compliance processes. Key areas include EDC, eTMF or ISF, CTMS, eConsent, Health Canada, FDA, and ICH-GCP requirements.

Key Responsibilities:

- Lead risk-based validation for GxP-impacting clinical trial technology systems
- Develop requirements, validation plans, risk assessments, and test protocols
- Maintain validated states through change control and periodic reviews
- Develop SOPs, policies, templates,



and compliance processes
- Support audits, inspections, remediation, training, and regulatory inquiries

Requirements:

- Bachelor's degree in a relevant health, science, research, or technology field
- Minimum seven years of clinical trials experience
- Knowledge of Health Canada, FDA, ICH-GCP, and TCPS 2
- Experience developing SOPs, policies, and regulatory processes
- Strong analytical, organizational, written, and verbal communication skills

Bring clinical trial regulations, computerized validation, and stakeholder collaboration expertise to SickKids’ compliant research operations.

📌 Clinical Research Compliance Lead (Toronto)
🏢 The Hospital for Sick Children
📍 Toronto