Senior Clinical Database Designer II

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

📋 Description

• Design clinical databases for new studies according to requirement specifications in various electronic data capture (EDC) systems.

• Implement post go-live modifications (database changes) based on revised requirement specifications in various EDC systems, providing impact assessments for those modifications.

• Conduct unit testing on the database design, support User Acceptance Test (UAT) activities, and address any findings from UAT.

• Carry out quality control (QC) reviews of databases developed by other designers.

• Set up and configure the development environment for new studies.

• Assist in creating the Database Integration Specification with other systems, providing necessary Integration Technical Details, and helping with integration and testing.

• Support the Data Manager in resolving issues related to database design.

• Aid in study decommissioning and archiving processes.

• Innovate new features and functionalities within the database design functional areas to enhance the efficiency of database design at the study level and to improve the company’s database design capabilities.

• Mentor and guide new Database Designers on procedures and best practices pertaining to database design.

• Review study design requirement specifications, ensuring compliance with EDC platform standards and Everest Standards along with best design practices.

• Contribute to the establishment of database design project timelines.

• Maintain database design timelines while promoting sound project management practices.

• Stay updated on regulatory requirements, industry trends, benchmarking, and best practices in data management and database design through continuous reading and participation in relevant training and association activities.

• Engage in technical learning and exchange meetings with EDC vendors, as well as other internal and external training sessions.

• Develop and maintain the company’s procedural documents, Work Instructions, checklists, guides, and templates for all EDC systems related to database design.

• Provide input for all data management procedural documents related to database design.

• Collaborate with the Quality Assurance department during QC audits on assigned databases.

• Validate and distribute real-time study monitoring reports to both the Sponsor and internal team members.

• Participate in and contribute to Clinical Data Management initiatives.

⛳️ Requirements

• B.Sc. in Biological Sciences or Computer Science.

• Five years of relevant experience.

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

• Effective oral and written communication skills with personnel at all professional and administrative levels.

• Demonstrated leadership and interpersonal skills in complex team environments.

• Exceptional presentation skills and the ability to foster relationships with both internal and external clients.

• Highly organized, capable of working independently, and managing multiple projects/tasks effectively.

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

🏝️ Benefits

• Flexible work arrangements.

• Professional development opportunities.