Clinical System Designer I

This is a fully remote position, open to applicants in Canada, +2 more countries.

📋 Description

• Design and create clinical systems that are in accordance with study protocols and operational requirements.

• Compile and finalize high-level system requirements documents and oversee their review process.

• Adapt and modify Case Report Forms (CRFs) from standard libraries and other research studies.

• Assist in and evaluate the reuse of library items.

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

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

• Facilitate eCRF and other specification review meetings.

• Adapt and utilize library edit checks for specific trial requirements.

• Program intricate dynamic checks and discrepancy edit checks.

• Monitor ongoing activities to identify tasks that fall outside the scope and report them to the Clinical Study Lead (CSL).

• Assist the CSL with timeline negotiations and study decision-making processes.

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

• Lead post-production database changes and releases into production.

• Provide refresher training to junior team members.

• Assess the activities and progress of assigned team members.

• Travel approximately 10% domestically and/or internationally.

⛳️ Requirements

• Minimum of 1 year of experience in the design and execution of clinical systems within the clinical research field.

• Proficient in data analysis and interpretation or Database Development, with familiarity in clinical data management systems and software.

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

• Functional expertise in CRF design tools and the ability to plan and create CDMS components based on the interpretation of medium complexity clinical trial protocols.

• Exceptional written and verbal communication abilities.

• Bachelor’s Degree in a relevant discipline.

• A combination of education, training, and relevant experience may be considered as a substitute for the stated education and experience requirements.

• All employees are required to read, write, and speak fluent English as well as the host country language.

• Applications must be submitted in English.

• Legal authorization to work in the country where the position is based is mandatory.

🏝️ 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 insurance and disability coverage.

• Employee assistance programs and wellness resources.

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

• Travel (approximately 10%) both domestically and/or internationally.