Medical Data Specialist

Job Description

Medical Data Specialist - Clinical Data Management (EDC/Medidata Rave)

Work mode: Hybrid
Onsite Location(s): Diegem, BRU, BE
Additional Locations: N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, well give you the opportunity to harness all thats within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information, and training, well help you in advancing your skills and career. Here, youll be supported in progressing whatever your ambitions.

About the role:

As a Medical Data Specialist at Boston Scientific, you will ensure the quality and integrity of clinical data by developing and maintaining data collection tools, management plans, database specifications, and edit checks. You will collaborate with cross-functional teams to support the execution of clinical trials by designing, validating, and maintaining electronic data capture (EDC) systems, with a focus on Medidata Rave. This is a vital role contributing to our mission of advancing science for life by ensuring accurate, timely, and compliant database development.

Work model:

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week.

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 companys 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 coach junior DMs including onboarding support

What we are looking for: Required qualifications:

• Bachelors degree in a technical or computer science discipline
• Minimum of 6 years' experience managing 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

Requisition ID: 614582

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isnt just business, its personal. And if youre a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you

Job Segment: Medical Lab, Medical Research, Clinical Research, Computer Science, Healthcare, Quality, Technology

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