Sr Application Specialist

The Hospital for Sick Children; Toronto; Hybrid; CAD 110,000 - 140,000; Full time

Benefits offered by this job

Health Insurance

Dental Insurance

Life Insurance

Hybrid work model

Employee benefits

Job summary

The Hospital for Sick Children (SickKids) in Toronto seeks a Senior Clinical Research Application Specialist to configure, support, and maintain validated platforms (EDC and eTMF/eISF). You will lead configuration, change control, and validation in partnership with vendors and research IT colleagues.

You will drive requirements translation, ensure compliance, and coordinate testing and documentation to support audit readiness within a collaborative, hybrid team.

Qualifications

• Bachelor's degree in health informatics, information systems, computer science, health sciences, or related discipline.
• Five+ years of experience implementing, configuring, validating, administering, or supporting enterprise applications in healthcare, research, life sciences, or a regulated environment.
• Hands-on administration experience with at least one clinical research platform (EDC or eTMF/eISF).
• Experience across application implementation and operations, including configuration, integration, testing, change control, and release management.
• Experience with computerized system validation and maintaining validated applications, including risk-based testing, validation documentation, and audit readiness.
• Knowledge of clinical research workflows, CRF design, data integrity, and access principles.
• Strong written communication skills and ability to work independently.

Responsibilities

• Collaborate with vendors and internal teams to plan, test, and implement configurations and releases across EDC and eTMF/eISF.
• Translate regulatory, privacy, and operational needs into technical requirements.
• Review vendor configurations for alignment with requirements and SickKids standards.
• Serve as primary technical contact with vendors for configuration questions and support escalations.
• Manage application changes through change control processes.
• Assess vendor releases for impact and coordinate regression testing.
• Maintain configuration specifications and change records for audit readiness.

Skills

Analytical thinking

Problem solving

Written communication

Independence & judgment

DEI commitment

Education

Bachelor's degree in health informatics / information systems / computer science

Tools

EDC platforms (e.g., EDC, eTMF/eISF)

Job description

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.

SickKids' Research Institute is modernizing its technology infrastructure to advance clinical research across the institution. Established in 2024 and aligned with SickKids' enterprise-wide Clinical Research Strategy, the Clinical Research Technology Program (CRTP) is building a regulatory-ready and sustainable digital ecosystem for clinical research. Technology will serve as a catalyst for connection, efficiency, and innovation by strengthening compliance and oversight, improving data integrity, streamlining research workflows, expanding patient participation, and enabling greater integration between research and care. As part of this work, the CRTP is introducing new clinical research platforms at SickKids, beginning with Electronic Data Capture (EDC) and electronic Trial Master File / electronic Investigator Site File (eTMF/eISF). Additional platforms related to the CRTP roadmap may be explored in the future. We are seeking a Senior Clinical Research Application Specialist to configure, support, and maintain the validated state of these new platforms. As a senior member of the Research IT Application Support team, you will serve as the primary application administrator for EDC and eTMF/eISF, leading configuration, change control, and validation activities in close partnership with vendors, Clinical Research Operations, and Research IT colleagues.

This is a new role that will evolve over the next two to three years as the portfolio expands and the supporting team grows.

Here’s What You’ll Get To Do

• Collaborate with vendors and internal teams to plan, review, test, and implement configurations, integrations, and releases across the EDC and eTMF/eISF platforms.
• Translate clinical research, regulatory, privacy, security, and operational needs into clear technical and configuration requirements.
• Review vendor‑proposed solutions and configurations for alignment with approved requirements, intended use, and SickKids standards.
• Serve as the primary technical contact with vendors for configuration questions, defects, and support escalations.
• Manage application changes through SickKids change control processes.
• Assess vendor releases and upgrades for impact on configuration, workflows, and validated state, and coordinate regression testing.
• Maintain configuration specifications and change records to support audit readiness.

Here’s What You’ll Need

• Bachelor’s degree in health informatics, information systems, computer science, health sciences, or a related discipline, or an equivalent combination of education and experience.
• Five or more years of experience implementing, configuring, validating, administering, or supporting enterprise applications in healthcare, research, life sciences, or another regulated environment.
• Hands‑on administration experience with at least one clinical research platform (e.g., EDC, eTMF/eISF) or a comparable regulated application.
• Demonstrated experience across application implementation and operations, including configuration, integration, testing, troubleshooting, change control, and release management.
• Experience with computerized system validation and maintaining validated applications, including risk‑based testing, validation documentation, and audit readiness.
• Knowledge of clinical research workflows, including CRF design, query management, data integrity, and role‑based access principles.
• Strong analytical, problem solving, and written communication skills.
• Ability to work independently, exercise sound judgment, and establish sustainable practices in an evolving service environment.
• Demonstrated commitment and actions in advancing equity, diversity, and inclusion objectives.

You Should Highlight If You Have

• Experience with EDC, eTMF/eISF, or comparable clinical research platforms.
• Knowledge of GAMP 5, 21 CFR Part 11, Health Canada expectations, electronic records and signatures, audit trails, and risk‑based validation.
• Experience with SaaS applications, identity and access management, APIs, system integrations, and reporting tools.
• Experience in a hospital, academic research, clinical research, or life‑sciences environment.
• Experience supporting audit‑or inspection‑ready systems and documentation.

About The Team

• Research IT is a collaborative team delivering project, product, application, and technical services across the SickKids Research Institute. Our diverse technology environment offers meaningful opportunities to solve complex challenges, develop new capabilities, and grow alongside supportive colleagues. We value collaboration, professional development, work‑life balance, and flexible hybrid work.
• As a senior member of the Application Support team, you will help shape a new clinical research technology service and build sustainable capabilities that enable research innovation and advance SickKids' vision of Unprecedented Outcomes Powered by Precision Child Health.

Here’s What You’ll Love

• This position is eligible for employee benefits coverage including but not limited to; health, dental and life insurance. The full benefits package will be discussed at the time of offer.
• A focus on employee wellness with our new Staff Health and Well‑being Strategy. Self‑care helps us support others.
• A hospital that welcomes and focuses on Equity, Diversity, and Inclusion.
• The opportunity to make an impact. Regardless of your role or professional interest, you will be making a difference at SickKids and contributing to our vision of Healthier Children. A Better World.

Employment Type

• Permanent full‑time
• 35 hours/week

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.

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.

Technical difficulties? Email [e-mail] with a short description of the issues you are experiencing. We will not accept resumes sent to this inbox but we are happy to respond to requests for technical assistance.

Every application is reviewed by a human recruiter and all hiring decisions are made by people. In some cases, AI‑assisted tools are used to help review applications based on job‑related qualifications.

All positions posted on the SickKids Hospital's Careers Site represent current vacancies, unless otherwise posted in the job description.