(Junior) Clinical Data Capture Designer
il y a 4 semaines
Job Description As part of the ongoing expansion of one of our client's Global Clinical Operations Department, they are currently looking for a Junior Clinical Data Capture Designer/eCRF Designer to join their Data Management (DM) team in Brussels. In this role, you will work closely with Clinical Data Managers and senior Study Designers. While Data Managers focus on reviewing and ensuring the accuracy of clinical data, your main responsibility will be to translate complex clinical study protocols into structured, functional electronic case report forms (eCRFs) in Medidata Rave, collaborating in pairs with a senior colleague. The company primarily uses Medidata Rave as their EDC platform. Responsibilities Collaborate closely with trial teams to analyse clinical study protocols and extract the data points that need to be collected in eCRFs. Translate study requirements into eCRF specifications, including questions, logic, edit checks, and branching, ensuring alignment with the protocol and study objectives. Implement the specifications in Medidata Rave, following an iterative, agile approach (batch-by-batch implementation) to refine forms and rules gradually. Reuse and adapt forms from previous studies whenever possible. Perform documentation, validation, and testing (including coordination with Biostatistics for verification of logic and data correctness). Support User Acceptance Testing (UAT) and ensure the final database is fully aligned with study needs. Maintain organized and comprehensive documentation throughout the database lifecycle. Requirements Master's degree in Life Sciences, Biomedical Sciences, Veterinary Science, Biomedicine, or Bioinformatics. 6 months to 2 years of relevant experience, ideally in a clinical research, EDC, or bioinformatics setting. Strong analytical and structured thinking, with the ability to break down complex study protocols into clear data collection requirements. Highly rigorous, detail-oriented, and adaptable, with good learning capacity. Enthusiastic, collaborative, and strong soft skills; able to work effectively in a structured environment. Understanding of case report forms (CRFs), logic implementation (edit checks, branching, calculated fields) and documentation processes. Full professional proficiency in English; French is a plus This position requires the ability to work on-site in Brussels, Belgium min. 3 days/week. Medidata Rave certification (Study Builder or Study Design & Build) is a plus, not mandatory. If the candidate does not already possess it, the certification will be provided by the client. Existing right to work in Europe is required. Additional Information Permanent contract Start Date: ASAP Schedule: full-time Hybrid working policy (3 days/week in the office + 2 days/week home-based)
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il y a 3 semaines
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il y a 7 jours
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