Medical Data Specialist - Clinical Data Management (EDC/Medidata Rave) at Boston Scientific Corporation Malaysia

Machelen, East Flanders, Belgium -

Full Time

Start Date

Immediate

Expiry Date

13 Jan, 26

Salary

0.0

Posted On

15 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Data Management, Electronic Data Capture, Medidata Rave, Data Management Documentation, Good Clinical Practices, Good Documentation Practices, Data Transfer Plans, Database Specifications, Edit Checks, User Acceptance Testing, Data Migration, Quality Systems, Regulatory Compliance, C#, SQL, Mentoring

Industry

Medical Equipment Manufacturing

Description

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 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 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 What we are looking for: Required qualifications: Bachelor's 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) 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!

Responsibilities

As a Medical Data Specialist, you will ensure the quality and integrity of clinical data by developing and maintaining data collection tools and management plans. You will collaborate with cross-functional teams to support the execution of clinical trials, focusing on electronic data capture systems like Medidata Rave.