Senior Clinical System Designer

Job description

**This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Clinical System Designer based in Canada.** As a Senior Clinical System Designer, you will play a key role in designing and implementing clinical systems that support the successful execution of clinical trials. You will translate study protocols and operational requirements into effective clinical database solutions and system specifications. The role combines clinical data expertise, system design, CRF development, edit check programming, and quality assurance. You will collaborate closely with study teams and project leads while contributing to important decisions around timelines, scope, and database changes. You will also support post-production enhancements and ensure that updates are carefully managed through to production release. This is a remote opportunity in Canada with approximately 10% domestic and international travel. ### 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.