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Data Manager for Clinical Trials
hace 2 meses
Job Title: Data Manager for Clinical Trials
Company: EURAXESS Czech Republic
Job Type: Full-time
Location: Remote
Job Category: Data Management
Job SummaryWe are seeking a highly skilled Data Manager to join our team in EURAXESS Czech Republic. The successful candidate will be responsible for designing and validating CRDs/e-CRDs, programming edit checks and data listings, and collaborating with statisticians in data analysis.
Key Responsibilities- Design and validation of CRDs/e-CRDs, as well as the programming of edit checks and data listings according to the required protocols and specifications.
- Develop specifications and procedures for data transfer to SAS according to the needs of statistical analysis.
- Clinical data processing, including CRD data review, query generation and resolution, data review, medical coding and quality control procedures.
- Prepare reports on the status of clinical trial data.
- DB closure tasks and all activities related to final data cleansing including contacting sites to resolve outstanding queries.
- Development of standard operating procedures (SOPs) for the standardisation of data management processes in clinical trials.
- Master's degree in Research in Clinical Medicine or equivalent.
- Previous experience as Clinical Data Manager acquired in CRO and/or collaborative groups.
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
- Knowledge of Database Management software (Advanced MACRO Training, Microsoft SQL Server (Administrator level)).
- Knowledge of Statistical Management software (SAS).
- Knowledge of Data Management Standards (SDTM and CDISH structures, OMOP Common Data Model).
- Knowledge of Medical Coding dictionaries (MedDRA Coding Training).
- Good Clinical Practice Training.
- Availability to travel and should possess a valid driving license.
- Indefinite-term employment contract for scientific and technical activities.
- Professional Category: Master's Degree Group II Area 2.
- Gross annual salary: 27,862.56€.
- Full time of 37.5 hours per week.
- Private matters: 6 working days per year.
- Vacation: 22 working days per year.
- Eligibility criteria: The selection process will consist of two phases and the following scale will be applied, out of a maximum of 10 points:
