For one of our clients, a medical device company, we are looking for a certified Medidata Rave (Junior) Clinical Database Developer to join their Data Management (DM) team.
Job Description
In this role, the Clinical Database Developer will work closely with Clinical Data Managers. While Data Managers focus on reviewing and ensuring the accuracy of clinical data, the Clinical Database Developer is responsible for designing and building the clinical study databases, including the setup and configuration of the Electronic Data Capture (EDC) system.
The company exclusively uses Medidata Rave as their EDC platform, so Medidata Rave certification is mandatory for this role.
Responsibilities
As Clinical Database Developer, you will be responsible for the full end-to-end setup of the Electronic Data Capture (EDC) system for clinical studies. Working closely with the study team, you will participate in the data mining phase to gather requirements, before proceeding to database design and implementation. Your role will also include documentation and coordination of User Acceptance Testing (UAT).
Key responsibilities include:
- Develop, program, validate, and maintain Medidata Rave EDC clinical trial databases in compliance with company and industry standards.
- Create EDC design specifications, including the data dictionary, event definitions, electronic consent forms, branching logic, edit checks, advanced query rules, calculated fields, and dynamic form/event rules.
- Develop test scripts and coordinate EDC User Acceptance Testing (UAT) to ensure the database functions as intended and meets protocol requirements.
- Collaborate with cross-functional study teams (Data Management, Clinical Operations, Biostatistics, etc.) to define data collection needs and ensure optimal database structure and usability.
- Maintain comprehensive documentation throughout the database lifecycle, from initial design through to final database lock.
Requirements
- Bachelor's or Master's degree in Life Sciences, Health Informatics, Computer Science, Biomedical Engineering, or a related field.
- Minimum 2-4 years of hands-on experience in EDC development, specifically with Medidata Rave, within the clinical research, CRO, or pharmaceutical industry.
- Experience in building and maintaining Rave databases across various clinical studies.
- One of the following certifications is mandatory : Medidata Rave EDC Study Builder or Medidata Rave Study Design and Build certification
- Strong knowledge of Medidata Rave, including CRF layout and design, edit checks, query rules, and system configuration.
- Experience in writing and executing User Acceptance Testing (UAT) scripts.
- Full professional proficiency in English (spoken and written) is required.
- Existing right to work in Europe is required
Additional information
- Full-time role
- 9 months of consultancy followed with a permanent contract from the client
- Candidates need to be located in Europe
- Remote working in the beginning, then hybrid with 3 days/week working from one of the client's European offices.
