Senior Clinical Database Designer

This is a fully remote position, open to applicants in Poland.

📋 Description

• Develop clinical databases for new studies in accordance with requirement specifications across various electronic data capture (EDC) systems.

• The design encompasses case report forms (CRF), edit checks, study roles, laboratory, coder, and RTSM.

• Implement post go-live modifications (database changes) as per updated requirement specifications in various electronic data capture (EDC) systems.

• Provide impact assessments for any modifications made.

• Conduct Unit Testing on the database design.

• Support User Acceptance Test (UAT) activities.

• Address findings from UAT.

• Establish and configure the development environment for new studies.

• Aid in the creation of the Database Integration Specification (DIS) with other systems.

• Offer Integration Technical Details (ITD) as required.

• Program the integration and assist during the integration testing phase.

• Assist the Data Manager (DM) in troubleshooting and resolving issues related to the database design.

• Support study decommissioning and archiving processes.

• Develop new features and functionalities within database design areas to enhance efficiency.

• Review the study design requirement specifications.

• Maintain timelines for database design and promote effective project management practices.

• Assist Clinical Data Management in strategizing, directing, and overseeing the clinical database design and maintenance processes.

• Stay updated on regulatory requirements, industry trends, and best practices by participating in training and related activities.

• Contribute to the development and upkeep of the company’s database design procedural documentation.

⛳️ Requirements

• Bachelor’s degree in Biological Sciences or Computer Science.

• Five years of relevant experience.

• Two to three years of experience in developing Inform, iDatafax/DFdiscover, Clinical One, and/or Medidata Rave (or similar) clinical databases.

• Must possess effective communication skills, both verbal and written, with personnel at all professional and administrative levels.

• Demonstrated leadership and interpersonal abilities in complex team environments.

• Excellent presentation skills and the capability to build relationships with both internal and external clients.

• Must be highly organized, capable of working independently, and proficient in managing multiple projects/tasks effectively.

• Proven ability to organize and integrate the activities of information processing personnel efficiently.

🏝️ Benefits

• Work from Home policy.

• Opportunities to work remotely.