Boston Scientific Medical Data Designer / Specialist - Clinical 

Belgium, Flemish Brabant 

374897260

Your responsibilities will include:

• 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 throughout all phases of the project lifecycle
• Design, develop, test, and maintain clinical data management systems, including EDC platforms such as Medidata Rave
• Provide support during 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-upon data sources into the EDC system
• Program, validate, and maintain Medidata Rave EDC clinical trial databases in accordance with company standards
• Create EDC design specifications, including data dictionaries, event definitions, electronic consent, branching logic, edit checks, advanced query rules, calculated fields, and dynamic rules
• Collaborate with Data Managers and study teams to design databases using global eCRF libraries
• Configure and optimize multiple patient user interfaces for various modes of data collection (eCOA, EDC)
• Conduct and manage Rave EDC migration activities
• Develop test scripts and coordinate EDC user acceptance testing (UAT)
• Deploy new or updated EDC databases into production environments
• Support mapping of EDC databases to the company’s enterprise data warehouse
• Drive continuous improvement by developing and implementing EDC design standards
• Contribute to the development and revision of department SOPs and maintain compliance with corporate and study-specific training requirements
• Provide input into the maintenance of quality systems and regulatory compliance
• Analyze protocols to identify, define, and map required data elements that align with protocol objectives, endpoints, and regulatory requirements while ensuring operational feasibility and data quality.
• (Preferred) Leverage experience with Medidata Custom Functions (C#/SQL)
• Mentor and coaching junior DMs including onboarding support

Required qualifications:

• Bachelor’s degree in a technical or computer science discipline
• Minimum of 6 years' experience managing / designing clinical studies in a data management role (Device, Pharma, or Biotech)

Preferred qualifications:

• Strong proficiency with electronic data capture (EDC) systems, particularly Medidata Rave

• Experience with Medidata Custom Functions (C# / SQL)
• Knowledge of enterprise data warehouse integration and data migration best practices
• Familiarity with quality systems, regulatory inspections, and SOP compliance in a clinical setting