Senior Clinical System Designer

Accountabilities: • Lead the design and development of clinical systems, ensuring that solutions align with study protocols, clinical requirements, and operational needs.

• Consolidate and complete high-level system requirements documentation, coordinate reviews, and ensure that specifications accurately reflect study needs.

• Copy, modify, and maintain CRFs from established libraries or previous studies, while supporting the appropriate reuse and review of standardized library components.

• Develop custom CRF screens, Edit Check specifications, and Dynamic Check specifications using prototyping methodologies when required.

• Conduct quality control and peer reviews of database-related specifications, documenting feedback and ensuring identified issues are appropriately addressed.

• Lead eCRF and other clinical system specification review meetings, facilitating alignment among relevant study stakeholders.

• Select and adapt appropriate edit checks from existing libraries and develop more complex dynamic and discrepancy checks to meet trial-specific requirements.

• Monitor study activities on an ongoing basis, identify tasks that fall outside the agreed scope, and escalate them to the appropriate study leadership.

• Support study leadership with timeline negotiations, scope discussions, and decision-making related to clinical database activities.

• Assess the impact of post-production database changes, prepare change management documentation, and coordinate reviews with project team leads.

• Drive approved post-production database changes through implementation and release into production while maintaining appropriate quality and documentation standards.

• Travel approximately 10% domestically and/or internationally as required by study or project needs.

Requirements

• Bring at least 5 years of experience designing and implementing clinical systems within the clinical research industry, with a strong understanding of clinical trial data and database processes.

• Demonstrate expertise in data analysis and interpretation or database development, together with practical experience using clinical data management systems and related software.

• Have hands-on knowledge of at least one Clinical Data Management System, such as Medidata Rave, Veeva EDC, or a comparable platform.

• Possess strong functional knowledge of CRF design tools and the ability to plan and design CDMS components directly from medium-complexity clinical trial protocols.

• Demonstrate excellent written and verbal communication skills, with the ability to explain technical and clinical database concepts clearly to different stakeholders.

• Hold a Bachelor’s degree in a relevant discipline or an equivalent combination of education and experience.

• Be legally authorized to work in Canada, as employment is contingent upon having the right to work in the country where the position is based.

Benefits

• Competitive base salary with performance-related incentives as part of a comprehensive total rewards package.

• Health and wellbeing programs that may include medical, dental, and vision coverage, depending on role and location.

• Retirement and pension programs designed to support long-term financial wellbeing.

• Life insurance and disability coverage where applicable.

• Employee assistance programs and additional wellbeing resources to support personal and professional wellbeing.

• Learning and development opportunities through structured training, professional development resources, and career pathways.

• Fully remote work within Canada, offering flexibility while working on international clinical research projects.

• An opportunity to contribute to clinical systems that support the development of new medicines and medical treatments for patients worldwide.

• An inclusive and accessible working environment where diverse perspectives are valued and reasonable accommodations are available throughout the recruitment process.

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