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.
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Clinical Research Compliance Lead in Toronto employer: The Hospital for Sick Children
At The Hospital for Sick Children (SickKids), we pride ourselves on being a leading employer in paediatric healthcare, offering a supportive and inclusive work environment that fosters professional growth and development. As a Program Manager, you will collaborate with top experts in the field, contributing to groundbreaking research while enjoying comprehensive benefits and a culture that prioritizes equity, diversity, and inclusion. Join us in our mission to create Healthier Children and a Better World, and be part of a community dedicated to making a meaningful impact in the lives of children and their families.
Contact Details:
The Hospital for Sick Children Recruitment Team
