System Designer

Job Title - Medidata RAVE - System Designer

Location - Remote

Role and Responsibility-

• Develop and maintain data management documentation and guidelines in accordance with Good Clinical Practices (GCP) and Good Documentation Practices (GDP).

• Provide subject matter expertise to project team members during all phases of project life cycle.

• Develop, test, and maintain data management systems.

• Provide subject matter expertise prior, during and post internal and external audits and inspections.

• Collaborate with Data Managers, Study Teams, Vendors, and Site Staff to formulate Data Transfer plans for secondary data sources (e.g., Lab data, Site data).

• Batch import agreed data sources into the EDC system.

• Develop, program, validate, and maintain Medidata Rave EDC clinical trial databases in accordance with company standards.

• Create EDC design specifications encompassing the data dictionary, event definitions, electronic consent, branching logic, edit checks, advanced query rules, calculated fields, and dynamic form and event rules.

• Work with Data Managers and study teams to design and construct the EDC database based on global eCRF libraries.

• Configure and optimize multiple patient user interfaces to support varying modes of data collection (eCOA- mobile device or tablet, EDC- laptop/desktop computer).

• Conduct, test, and produce Rave EDC Migration activities as required.

• Develop test scripts and coordinate EDC user acceptance testing (UAT) to ensure accuracy of database structure, content, and validation controls aligned with the original specifications.

• Coordinate and manage the deployment of new or modified EDC databases into production.

• Assist in mapping the EDC database to the company enterprise data warehouse.

• As part of continuous improvement efforts, develop and implement EDC design standards to enhance quality and streamline database build proc

• Be available to work on any studies

• Work according to SOPs/WI