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 Systems
- Perform Quality Control reviews of all CSV Package documents
- Maintain the Change Review Log and prepare Change Control Board minutes for review during Change Control Board meetings
- Maintain CSV Package Table of Contents for all systems
- Perform Comprehensive System Periodic Reviews per defined procedures
- Execute assigned testing efforts in the Test Management System
- Review test scripts executed by other CSV Team members
- Close out all testing efforts, including:
- Quality Control of testing efforts for completeness and accuracy
- Generation and filing of testing documentation per SOP 12.2, Formal Testing Practices for GCP Systems, and associated TMRS work instructions
- Author ongoing Test Summary Reports and assist in the preparation of all other CSV Package plans and reports
- Provide occasional evening and weekend support as required
Level 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 applications
- Exceptional attention to detail, organizational, and time‑management skills
- Self‑starter with the ability to work independently as well as collaboratively within a team
- Excellent written and verbal communication skills in English, with the ability to produce clear technical documentation
Level 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 considered
- Minimum of 2 years of relevant experience in software testing, business analysis and project management
- Technical Writing experience required
- Experience working in a regulated environment is an asset
- Training or experience in Computerized Systems Validation (CSV) and/or User Acceptance Testing (UAT) is an asset
- Experience executing test scripts and using test management software is an asset
What TRIO Can Offer You:
- Annual compensation review with opportunities for professional growth
- 3 weeks of vacation plus paid December Holiday Closure
- 10 days paid personal/sick time
- 1 paid volunteer day / year
- A rich benefit plan with Health, Dental, Vision & Life Insurance premiums paid by TRIO
- Up to 5% RRSP Matching Program
- Voluntary TFSA Program Available
- Flexible working hours to create work-life balance
- Monthly Internet Allowance to support working from home and a one-time Home Office Allowance
- Out-of-country Work: Employees can request to work internationally for a short period of time each year
- Maternity / Parental Leave Top-Up Program
- Employee Family Assistance Program to support you and your family during difficult times
- Employee Recognition Program to reward long-term employees
- Employee Referral Bonus Program
Level l Pay Range: $45,000.00 to $52,500.00
Level ll Pay Range: $52,500.00 to $60,000.00
Salary to be influenced (or determined) by the education, experience, location, knowledge, skills, abilities of the applicant, internal equity, and alignment with market data.
