Our client, a global leader in the medical technology industry, is seeking a Medical Data Specialist to join its high-performing clinical operations division. This organisation is recognised worldwide for its innovative culture, strong employee development philosophy, and commitment to improving patients' lives.
In this role, you will contribute directly to the quality and integrity of clinical data by designing, validating, and maintaining Electronic Data Capture (EDC) systems, particularly within Medidata Rave. You will work cross-functionally to support the execution of clinical trials and ensure database accuracy, compliance, and readiness throughout the project lifecycle.
This position follows a hybrid setup, requiring presence in the local office at least three days per week.
Medical Data Specialist (EDC / Medidata Rave)
Functieomschrijving
This role offers a genuine springboard into a future management position, with the opportunity to lead a team of 4 to 8 people in the medium term. From the very beginning, you will mentor and coach junior data managers and support their onboarding, positioning you naturally for a progressive step into leadership:
- Develop and maintain data management documentation in line with GCP and GDP standards.
- Act as subject-matter expert for project teams throughout all study phases.
- Design, develop, test, and maintain clinical data management systems, including EDC platforms (primarily Medidata Rave).
- Provide support during internal and external audits and regulatory inspections.
- Collaborate with Data Managers, study teams, vendors, and sites to create data transfer plans for secondary data sources (lab data, site data, etc.).
- Import and manage data batches within the EDC environment.
- Program, validate, and maintain Rave EDC databases following internal standards.
- Create detailed EDC design specifications (data dictionaries, event definitions, logic rules, edit checks, dynamic rules, etc.).
- Use global eCRF libraries to support database design.
- Configure multi-interface patient data collection systems (eCOA, EDC).
- Lead and execute EDC migration activities.
- Develop test scripts and coordinate User Acceptance Testing (UAT).
- Deploy new or updated EDC databases into production systems.
- Support mapping of EDC structures to the organisation's enterprise data warehouse.
- Drive continuous improvement by contributing to EDC design standards.
- Participate in the development and updating of departmental SOPs and ensure compliance with quality and training requirements.
- Analyse study protocols to define data elements aligned with endpoints, objectives, and regulatory expectations.
- (Preferred) Utilise experience with Medidata Custom Functions (C# / SQL).
Profiel
- Bachelor's degree in a technical, scientific, or computer science field.
- Minimum 6 years of experience in clinical data management within Medical Devices, Pharma, or Biotech.
- Preferred Qualifications
- Strong proficiency with Medidata Rave and EDC systems.
- Experience with Medidata Custom Functions (C# / SQL).
- Understanding of enterprise data warehouse structures and data migration best practices.
- Familiarity with quality systems, regulatory inspections, and SOP compliance in a clinical research environment.
Aanbod
A strategic and evolving role
- A key position in clinical Data Management, with real impact on the quality and integrity of clinical trial data.
- Strong cross-functional exposure: collaboration with clinical teams, data teams, IT, external vendors, etc.
- Access to the latest tools and technologies (including Medidata Rave).
Real career progression
- Continuous skill development (training, tools, internal certifications).
- Potential to grow into a managerial role, leading a team of 4 to 8 Data Managers in the mid-term.
- Challenging package
A flexible work model
- Hybrid organization: 3 days per week in the office, offering a balance between collaboration and autonomy.
Leadership & influence
- Mentoring and coaching junior Data Managers from day one.
- Involvement in onboarding and supporting new team members.