Senior Clinical System Designer

This is a fully remote position, open to applicants in Canada.

📋 Description

• Oversee the design and development of clinical systems in accordance with study protocols and operational requirements.

• Compile and finalize high-level system requirement documents and facilitate their review process.

• Adapt and modify CRFs from standard libraries and previous studies.

• Assist in the evaluation and reuse of library items.

• Create custom CRF screens, Edit Check, and Dynamic Check specification documents utilizing prototyping methodologies as required.

• Conduct quality control peer reviews of database-related specifications and document feedback.

• Facilitate eCRF and other specification review meetings.

• Apply and adjust library edit checks to fulfill trial-specific needs.

• Program intricate dynamic checks and discrepancy edit checks.

• Monitor ongoing activities for tasks that fall outside of the scope and report them to the CSL.

• Assist the CSL in negotiating timelines and making study-related decisions.

• Evaluate the impacts of post-production database modifications and prepare change management documentation.

• Lead post-production database modifications and ensure their release into production.

• Travel approximately 10% for domestic and/or international assignments.

⛳️ Requirements

• A minimum of 5 years of experience in designing and implementing clinical systems within the clinical research field.

• Proficiency in data analysis and interpretation or Database Development, with strong expertise in clinical data management systems and software.

• Familiarity with at least one Clinical Data Management System (such as Medidata Rave, Veeva EDC, etc.).

• Strong functional understanding of CRF design tools and the capability to plan and design CDMS components based on the interpretation of medium complexity clinical trial protocols.

• Exceptional written and verbal communication skills.

• Bachelor’s Degree in a related field.

• Legal authorization to work in Canada.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life assurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.