Clinical Research Regulatory Compliance Lead

About SickKids

Dedicated exclusively to children and their families, The Hospital for Sick Children (SickKids) is one of the largest and most respected paediatric healthcare centres in the world. As innovators in child health, we lead and partner to improve the health of children through the integration of healthcare, leading-edge research and education. Our reputation would not have been built - nor could it be maintained - without the skills, knowledge and experience of the extraordinary people who come to work here every day. SickKids is committed to ongoing learning and development, and features a caring and supportive work environment that combines exceptionally high standards of practice.

When you join SickKids, you become part of our community. We share a commitment and determination to fulfill our vision of Healthier Children. A Better World.

Don't miss out on the opportunity to work alongside the world's best in paediatric healthcare.

Position Description

SickKids' Clinical Research Operations is seeking a highly motivated Clinical Research Regulatory Compliance Lead with expertise in clinical trials, regulatory affairs, and computerized system validation. As SickKids advances its commitment to Precision Child Health (PCH), and in alignment with SickKids' Clinical Research Strategy 2030, we are building a robust Regulatory and Compliance program that provides comprehensive institutional oversight, streamlined processes, and standardized SOPs, and validated technology solutions to support innovative, high quality, and safe clinical trials.

This role supports two strategic priorities at SickKids. The first is the Clinical Research Technology Program, which oversees the procurement, implementation, validation, and lifecycle management of clinical research technology solutions, including EDC, TMF/ISF, CTMS, eConsent, and related integrations. The Regulatory Compliance Lead will provide regulatory and validation expertise throughout system selection and implementation by supporting requirements definition, risk-based validation planning, protocol development and execution, deviation management, validation reporting, change control, and maintenance of the validated state.

The second strategic area is providing regulatory and compliance subject matter expertise to Clinical Research Operations teams, with a particular focus on SickKids-sponsored regulated clinical trials. This includes developing and implementing standardized SOPs, guidelines, and tools that enable consistent and compliant practices across Clinical Research Operations functions and study teams.

The successful candidate will have strong knowledge of clinical trial regulations, with experience in the computerized system validation and regulatory oversight of clinical research technology systems considered a strong asset. This role requires strong collaborations and works closely with stakeholders across SickKids, including various Research Operations and Clinical Research Operations teams, Research IT, study teams, clinical service providers and external regulatory agencies. The position plays a key role in advancing efficient, high quality, and compliant clinical research at SickKids.

Here's What You'll Get to Do:

• Provide leadership, subject matter expertise, and hands on support for the risk based validation of GxP-impacting clinical trial technology systems during selection and implementation. This includes defining user and functional requirements; developing validation plans, risk assessments, traceability matrices, and test protocols; coordinating user acceptance testing; managing deviations and CAPAs; and preparing validation summary reports in accordance with applicable data integrity and electronic records requirements, including ALCOA+, GAMP 5, and 21 CFR Part 11.
• Maintain computerized systems in a validated state after implementation by overseeing change control, risk-based revalidation, periodic reviews, and continuous improvement. Establish and maintain the governance framework, SOPs, policies, templates, work instructions, and processes required for ongoing computerized system validation and data integrity compliance.
• Provide expert regulatory guidance across the clinical trial and digital system lifecycle, interpreting and communicating applicable regulations and guidance (e.g., Health Canada, FDA, ICH'GCP, TCPS2, privacy and data protection requirements).
• Advise on the regulatory and compliance requirements that inform the procurement and implementation of clinical research technologies, including EDC, eTMF/ISF, CTMS, eConsent, and related integrations.
• Develop, implement, and maintain regulatory and compliance policies, SOPs, templates, and processes for clinical research operations, including documentation, privacy, and other applicable regulatory requirements.
• Assess compliance risks, conduct reviews or audits as needed, and support remediation activities, including CAPA development and continuous improvement initiatives. Translate regulatory requirements into practical, scalable operational processes for clinical research teams and digital systems.
• Collaborate with Clinical Research Operations, Research IT, investigators, study teams, and other stakeholders to embed regulatory compliance into day-to-day research activities.
• Support training and education initiatives by contributing to regulatory training materials and delivering guidance to diverse audiences.
• Liaise with regulatory authorities and support responses to inquiries, audits, and inspections related to clinical research and research technologies, as required.

Here's What You'll Need:

Required

• Bachelor's degree in a health', life science', research', computer science, technology-related field or relevant.
• Minimum of seven years of experience in clinical trials, including:
• Direct experience managing regulated clinical trials. Strong working knowledge of Health Canada and FDA regulations, ICH-GCP, TCPS 2, electronic records requirements, and risk-based validation approaches; knowledge of GAMP 5, ALCOA+, and 21 CFR Part 11.
• Demonstrated experience developing and implementing SOPs, policies, and regulatory processes.
• Strong analytical, organizational, written, and verbal communication skills, with the ability to manage multiple priorities and collaborate effectively with diverse stakeholders in a fast-paced, cross-functional environment.
• Proven ability to work collaboratively in cross-functional teams and balance multiple priorities in a fast-paced environment.
• Understand importance and demonstrates ability to foster a culture of Equity, Diversity, and Inclusion.

Assets / Preferred

• Advanced degree in health sciences, life sciences, computer science, engineering, healthcare administration, or a related field (e.g., master's, MBA).
• Postgraduate certificate in clinical research, regulatory affairs, quality, or computerized system validation.
• SoCRA or ACRP certification.
• Experience with audits, inspections, and regulatory interactions. Familiarity with data privacy, data integrity, and digital compliance requirements (e.g., 21 CFR Part 11, PIPEDA, GDPR, HIPAA).
• Project management experience supporting system implementations or process standardization initiatives.

Employment Type:

• 2-year contract with opportunity to extend (full time with end date)
• Hybrid

Our Commitment to Diversity

SickKids is committed to championing equity, diversity and inclusion in all that we do, fostering an intentionally inclusive and culturally safe environment that reflects the diversity of the patients, families and communities we serve. Learn more about workplace inclusion.

Accessibility & Accommodation

If you require accommodation during the application process, please reach out to our aSKHR team. SickKids can provide access and inclusion supports to eligible candidates to support their full engagement during the interview and selection process as well as to ensure candidates are able to perform their duties once successfully hired. If you are invited for an interview and require accommodation, please let us know at the time of your invitation to interview. Information received related to access, inclusion or accommodation will be addressed confidentially.

How To Apply

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