Boston Scientific Gruppe
Medical Data Specialist - Clinical Data Management (EDC/Medidata Rave)
Boston Scientific Gruppe, Sauk Trail Beach, Wisconsin, United States
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Medical Data Designer / Specialist - Clinical Data Management (EDC / Medidata Rave) Onsite Location(s):
Diegem, BRU, BE
Additional Locations:
N/A
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance
At Boston Scientific, we’ll give you the opportunity to harness all that’s 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, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.
About the role: As a Medical Data Designer / 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.
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.
Responsibilities:
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
Qualifications: 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
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) isn’t just business, it’s personal. And if you’re 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, Data Warehouse, Computer Science, Healthcare, Technology
#J-18808-Ljbffr
Medical Data Designer / Specialist - Clinical Data Management (EDC / Medidata Rave) Onsite Location(s):
Diegem, BRU, BE
Additional Locations:
N/A
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance
At Boston Scientific, we’ll give you the opportunity to harness all that’s 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, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.
About the role: As a Medical Data Designer / 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.
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.
Responsibilities:
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
Qualifications: 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
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) isn’t just business, it’s personal. And if you’re 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, Data Warehouse, Computer Science, Healthcare, Technology
#J-18808-Ljbffr