For one of our clients in Brussels region, a medical device company, we are urgently looking for a Clinical data manager to reinforce their team.
Previous experience is a plus, but not required. If you are interested in databases, fluent in English, and have strong communication skills, don't hesitate to apply!
As a Clinical data manager, you play a key role in clinical research by controlling the information captured during a clinical trial. They ensure the quality and integrity of clinical data via the creation of tools such as data collection instruments, data management plans, database specifications, and reports, as well as the review of clinical data for completeness, accuracy, and consistency. You achieve this through collaboration with clinical colleagues (e.g., Project Management, Trial Operations, Site Operations, IT, Global Safety, Biostatistics, Quality and Medical Sciences) and other cross functional team members (e.g., Legal and Regulatory).
- Define the data validation specifications and perform the review of clinical data for completeness, accuracy and consistency in accordance with the investigational plan.
- Facilitate timely data entry by mobilizing and providing assistance to research sites having data entry difficulties.
- Develop and maintain data management documentation and guidelines in accordance with Good Clinical Practices (GCP) and Good Documentation Practices (GDP).
- Define data management timelines according to the study milestones.
- Provide subject matter expertise to project team members during all phases of project life cycle.
- Provides accurate and timely clinical data to internal and external customers upon request.
- Work with database programmers to design and validate electronic case report forms (eCRFs) in electronic data capture (EDC) system.
- Provide subject matter expertise prior, during and post internal and external audits and inspections.
- Maintain compliance with corporate, core and study-specific learning requirements.
- Master’s degree or PhD in Biomedical Sciences, paramedical or related field.
- Interest in databases. Knowledge of SQL or software like SAS, SPSS, R, is a plus.
- Interest in clinical trials.
- Good knowledge of English (speaking, writing, comprehension).
- Good communication skills.
- Positive attitude, analytical mind, structured and organized.
015 21 11 04