Clinical Data Manager-Madrid, Spain
Job Description
Sermes CRO is seeking a Clinical Data Manager to join its Biometrics team within the Data Management area in Madrid. This is a permanent, full-time position of 40 hours per week, with a hybrid working arrangement consisting of 2 days of remote work and 3 days on-site.
The role involves managing Data Management activities end-to-end, from study set-up through database lock. Responsibilities include defining data quality and study risk strategies, designing eCRFs, databases and EDC validations, and preparing and maintaining the Data Management Plan (DMP). The position also includes supervising data cleaning, queries and reconciliations involving SAEs, laboratories and ePRO, as well as coordinating with CRAs, Biostatistics, Programming, Safety and external vendors.
The Clinical Data Manager will help ensure compliance with ICH-GCP, 21 CFR Part 11 and CDISC standards, participate in audits and regulatory inspections, and maintain the relevant TMF/eTMF documentation.
Candidates should have at least 3 years of relevant experience and advanced clinical data management knowledge. A relevant degree and medium-high English with high-level Spanish are required.
Requirements
- Minimum 3 years of experience in data analysis, biometrics and/or similar functions in a clinical research or CRO environment.
- Advanced knowledge of clinical data management.
- Proficiency with Data Management tools and applications.
- Ability to manage multiple projects simultaneously while maintaining rigor and quality.
- Excellent communication skills and results orientation.
- Meticulous, organized profile with attention to detail.
- Medium-high level of English and high level of Spanish.
- Degree or Bachelor's degree in Statistics, Mathematics, Analysis Methodology, Health Sciences or related fields.
- Knowledge of CDISC (SDTM, CDASH), MedDRA and WHODrug.
- Advanced knowledge of Word.
- High level of Excel and PowerPoint.
- Knowledge of complex and non-traditional data management, such as Wearables, ePRO/eCOA and RWD, is valued.
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