Computer Systems Validation Assistant

Translational Research in Oncology (TRIO) is a global academic clinical research organization dedicated to advancing translational cancer research in the clinical trial setting. Our passionate team is committed to providing cancer treatments of the future to the world of today.TRIO is looking for a Computer Systems Validation Unit Associate I or ll to join our Quality Assurance team. Reporting to the QA CSV Unit Manager this position will be home based in Canada. The level (I or II) will be determined based on the successful candidate’s qualifications and experience.Level l Responsibilities:Assist in the development and update of all CSV Package documents for GCP SystemsPerform Quality Control reviews of all CSV Package documentsMaintain the Change Review Log and prepare Change Control Board minutes for review during Change Control Board meetingsMaintain CSV Package Table of Contents for all systemsPerform Comprehensive System Periodic Reviews per defined proceduresExecute assigned testing efforts in the Test Management SystemReview test scripts executed by other CSV Team membersClose out all testing efforts, including:Quality Control of testing efforts for completeness and accuracyGeneration and filing of testing documentation per SOP 12.2, Formal Testing Practices for GCP Systems, and associated TMRS work instructionsAuthor ongoing Test Summary Reports and assist in the preparation of all other CSV Package plans and reportsProvide occasional evening and weekend support as requiredLevel ll Responsibilities:The Associate II level is responsible for all duties outlined under the Associate I level, in addition to the responsibilities listed below.Lead the preparation, execution, and maintenance of Computer System Validation (CSV) packages for clinical systems, including authoring validation plans, test plans, test scripts, user requirements, and summary reports.Serve as the primary Validation Lead for one or more clinical systems, overseeing end‑to‑end validation and testing activities.Lead Change Control Board meetings and system review discussions to support approval of system validation documentation.Facilitate system package review meetings with senior leadership prior to final approval.Participate in internal and external audits related to CSV activities and regulated systems.Contribute to the development and revision of CSV‑related procedures, work instructions, and training materials.Provide training, guidance, and ongoing support to users of the Test Management System.Level l Qualifications:Intermediate to Advanced proficiency with Microsoft Office applicationsExceptional attention to detail, organizational, and time‑management skillsSelf‑starter with the ability to work independently as well as collaboratively within a teamExcellent written and verbal communication skills in English, with the ability to produce clear technical documentationLevel ll Qualifications:The Associate II level is required to have all qualifications outlined under the Associate I level, in addition to the qualification listed below.Diploma in Information Technology or a related program. A combination of education and work experience will be consideredMinimum of 2 years of relevant experience in software testing, business analysis and project managementTechnical Writing experience requiredExperience working in a regulated environment is an assetTraining or experience in Computerized Systems Validation (CSV) and/or User Acceptance Testing (UAT) is an assetExperience executing test scripts and using test management software is an assetWhat TRIO Can Offer You:Annual compensation review with opportunities for professional growth3 weeks of vacation plus paid December Holiday Closure10 days paid personal/sick time1 paid volunteer day / yearA rich benefit plan with Health, Dental, Vision & Life Insurance premiums paid by TRIOUp to 5% RRSP Matching ProgramVoluntary TFSA Program AvailableFlexible working hours to create work-life balanceMonthly Internet Allowance to support working from home and a one-time Home Office AllowanceOut-of-country Work: Employees can request to work internationally for a short period of time each yearMaternity / Parental Leave Top-Up ProgramEmployee Family Assistance Program to support you and your family during difficult timesEmployee Recognition Program to reward long-term employeesEmployee Referral Bonus ProgramLevel l Pay Range: $45,000.00 to $52,500.00Level ll Pay Range: $52,500.00 to $60,000.00Salary to be influenced (or determined) by the education, experience, location, knowledge, skills, abilities of the applicant, internal equity, and alignment with market data.  

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