Principal Clinical System Designer

This is a fully remote position, open to applicants in Colombia, +1 more country.

📋 Description

• Direct the design and development of clinical systems that align with study protocols and operational requirements.

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

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

• Assist in the evaluation and reuse of library items.

• Create Custom CRF screens, Edit Check, and Dynamic Check specification documents employing prototyping methodologies as necessary.

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

• Facilitate eCRF and other specification review meetings.

• Utilize and adjust library edit checks to fulfill trial-specific requirements.

• Program intricate dynamic checks and discrepancy edit checks.

• Monitor ongoing activities to pinpoint out-of-scope tasks and escalate these to the CSL.

• Assist the CSL in timeline negotiations and decision-making for studies.

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

• Lead post-production database modifications and implement them into production.

• Travel approximately 10% domestically and/or internationally.

⛳️ Requirements

• Over 4 years of experience in designing and implementing clinical systems within the clinical research sector.

• Proficiency in data analysis and interpretation or Database Development.

• Skilled 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 knowledge of Clinical Data Management CRF design tools.

• Capability to plan and design CDMS components based on the interpretation of medium complexity clinical trial protocols.

• Exceptional written and verbal communication abilities.

• A combination of education, training, and relevant experience may be accepted in lieu of the educational and experiential requirements outlined above.

• Must possess proficiency in reading, writing, and speaking fluent English and the host country language.

• Must have the legal authorization to work in the country where the position is located.

• Applications must be submitted in English.

🏝️ 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.

• Learning and development opportunities through structured training and career pathways.