Department of Community Health Sciences

Rady Faculty of Health Sciences

Position number: 37631

Date posted: May 4, 2026

Job details

Comp System Validation & Data Mgmt Analyst - IT3 (AESES)

New Project Full-Time (Budget Funded)

Full-time:

Yes

Permanent:

No

Work schedule:

35 Hours/week (Monday to Friday, 8:00 am to 4:00 pm)

Salary:

$33.08 to $47.72 per hour ($60,205.60 to $86,850.40 per annum)

Appointment Dates

June 8, 2026 to June 4, 2027

Trial/Probation period:

840 hours worked

For more information please contact: Andrea Toyne - andrea.toyne@umanitoba.ca

Qualifications

MINIMUM FORMAL EDUCATION/TRAINING REQUIRED:

• Post-secondary degree in Computer Science, Information Systems, Engineering, IT Operations, Cybersecurity, Clinical Trials and Regulatory Affairs, or a related scientific/technological discipline.

EXPERIENCE:

• At least one year of direct experience in Computerized System Validation (CSV) where it was a primary & full-time responsibility, is a very strong asset.
• Direct experience with Quality Assurance in software development is preferred.
• Experience ensuring compliance with ICH-GCP, Health Canada Division 5, 21 CFR Part 11, the Tri-Council Policy Statement on the Ethical Conduct for Research Involving Humans (TCPS), and the Personal Health Information Act of Manitoba (or equivalent local privacy legislation) is a strong asset.
• Experience with clinical research involving human participants is an asset.
• Experience with full-stack web development/administration, including HTTP server technology, computer networking, server-side scripting, database administration, and knowledge of Microsoft Internet Information services (IIS) and virtualization environments, are all assets.
• Experience with Electronic Data Capture (EDC) systems, such as REDCap, is highly valued.
• Experience with Health Canada regulated clinical trials and the associated data collection processes is preferred.
• An equivalent combination of education and experience may be considered.

SKILLS AND ABILITIES:

• A strong understanding of Computerized System Validation and software Quality Assurance principles, including risk-based testing and validation documentation, is essential.

• Practical working knowledge of probability theory and statistics.

• Excellent oral and written communication skills are essential, including the ability to clearly communicate technical information to both technical and non-technical audiences.

• Ability to set priorities, multi-task, and work effectively under time-constrains required.

• Must be able to work in complex team environment with researchers, clinicians, and representatives from external agencies, such as government departments.

• Must be able to work independently with minimal supervision.

• Ability to diagnose and resolve software and system problems is required.

• Ability to develop strong interpersonal working relationships is required.

• Satisfactory work record, including satisfactory attendance and punctuality, is required.

Key responsibilities

Responsibilities:

Develop and implement of a Computerized System Validation (CSV) framework for Electronic Data Capture (EDC) systems (REDCap) at the University of Manitoba:

• Develop a Computerized System Validation Plan for REDCap systems at the University of Manitoba.
• Improve, write, and finalize Standard Operating Procedures (SOPs) and develop associated workflow processes described by the Validation Plan.
• Ensuring that the REDCap infrastructure administered by IT department complies with standards that the Analyst will help develop. Analyst will work directly with the IT department to configure REDCap application stack in compliance with the Validation Plan and SOPs. Analyst will be directly responsible for performing, documenting, and validating installations and upgrades to REDCap application stack.
• Develop and use a REDCap database project to identify Critical-to-Quality factors in EDC processes, determine associated risks, perform and record testing, and report validation status throughout the system lifecycle.
• Monitor current and emerging regulatory guidance (e.g., ICH-GCP, Health Canada Division 5) and ensures that corresponding updates are implemented and documented within Validation Plan and SOPs.
• Collaborates with external institutions involved in centralized validation efforts, providing in-kind consultation and testing support.
• Develops a genericized version of the Validation Plan/SOPs suitable for adoption by other institutions running REDCap, and takes an active role in a pan-Canadian validation committee for institutions running REDCap. If possible, the analyst will be supported by the DCC Lead in the authorship of a publication in trade/scientific journals detailing their methodology.
• Develops and implements a framework for testing the accuracy, safety, and security of external software modules integrated into REDCap systems.
• Responds to audits and inspections by regulatory authorities. Provides, explains, and contextualizes CSV documentation in the context of regulatory inspections.
• Develops and enforces risk-proportionate quality assurance (QA) standards and processes for statistical programming. Ensures that data processing activities and study status reports provided to investigators are accurate, validated, and compliant with established QA standards.

Data Management:

• Develops and maintains an understanding of REDCap project design in the context of clinical research and Health Canada regulated clinical trials.

• Designs, maintains, and improves REDCap database projects for research and operational uses.

• Performs basic descriptive analysis, data quality monitoring, data processing, and visualizations of imperfect datasets using the R programming language.

• Assists with REDCap system administration, including user and project management, compliance monitoring, and training coordination.

• Schedules and coordinates training events in consultation with relevant user and stakeholder groups.

• Responds to REDCap enquiries from the research community and troubleshoots research database issues.

• May be required to perform related duties not exceeding skills and capabilities as required.

Additional information

The University of Manitoba is committed to the principles of equity, diversity & inclusion and to promoting opportunities in hiring, promotion and tenure (where applicable) for systemically marginalized groups who have been excluded from full participation at the University and the larger community including Indigenous Peoples, women, racialized persons, persons with disabilities and those who identify as 2SLGBTQIA+ (Two Spirit, lesbian, gay, bisexual, trans, questioning, intersex, asexual and other diverse sexual identities).

If you require accommodation supports during the recruitment process, please contact UM.Accommodation@umanitoba.ca or 204-474-7195. Please note this contact information is for accommodation reasons only.

Application materials, including letters of reference, will be handled in accordance with the protection of privacy provisions of "The Freedom of Information and Protection of Privacy Act" (Manitoba). Please note that curriculum vitae will be provided to participating members of the search process.