Senior Clinical System Designer

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

📋 Description

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

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

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

• Assist in reviewing the reuse of library items.

• Create Custom CRF screen, Edit Check, and Dynamic Check specification documents using necessary prototyping methodologies.

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

• Facilitate eCRF and other specification review meetings.

• Utilize and adjust library edit checks to meet trial-specific needs.

• Program intricate dynamic checks and discrepancy edit checks.

• Monitor ongoing activities for tasks that fall outside the scope and escalate these to the Clinical Study Lead (CSL).

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

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

• Manage the implementation of post-production database changes and releases into production.

• Willing to travel approximately 10% domestically and/or internationally.

⛳️ Requirements

• Minimum of 3 years' experience in designing and implementing clinical systems within the clinical research sector.

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

• Familiarity with at least one Clinical Data Management System (e.g., Medidata Rave, Veeva EDC).

• Strong functional knowledge of Clinical Data Management CRF design tools.

• Ability to plan and design CDMS components directly 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 considered as an alternative to the stated education and experience requirements.

• Proficiency in English and the host country language, including reading, writing, and speaking skills.

• Applications must be submitted in English.

• Must have the legal right to work in the country where the position is based.

🏝️ 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.