Clinical Research Compliance Lead

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 systemsDevelop requirements, validation plans, risk assessments, and test protocolsMaintain validated states through change control and periodic reviewsDevelop SOPs, policies, templates, and compliance processesSupport audits, inspections, remediation, training, and regulatory inquiriesRequirements:
Bachelor's degree in a relevant health, science, research, or technology fieldMinimum seven years of clinical trials experienceKnowledge of Health Canada, FDA, ICH-GCP, and TCPS 2Experience developing SOPs, policies, and regulatory processesStrong analytical, organizational, written, and verbal communication skillsBring clinical trial regulations, computerized validation, and stakeholder collaboration expertise to SickKids’ compliant research operations.
#J-18808-Ljbffr