Clinical Data Manager 50%

Job description

Join HEMEX, A European Contract Research Organization based in Liestal, Switzerland, dedicated to advancing global healthcare through innovative biotechnology research. As a Medical Monitor specializing in Pharmacovigilance and Medical Device Safety, you'll play a crucial role in ensuring the safety and efficacy of groundbreaking pharmaceutical, biotech, and medtech solutions. With our comprehensive clinical development services, including regulatory support and quality assurance, you'll have the opportunity to work on multinational clinical trials and contribute to the translation of novel concepts into market-ready solutions. Tasks The Clinical Data Manager is responsible for the planning, setup, conduct, cleaning, reconciliation, and closeout of clinical trial databases. The role ensures that clinical trial data are complete, consistent, accurate, traceable, and ready for statistical analysis and database lock. The Clinical Data Manager works closely with Clinical Operations, CRAs, Medical Monitors, Pharmacovigilance, Biostatistics, investigators, and sponsors throughout the study lifecycle. Functional Responsabilities: 1. Study Setup and Database Build Translate clinical trial protocols and endpoints into electronic Case Report Forms (eCRFs). Develop eCRF specifications in alignment with applicable CDISC (CDASH and SDTM) standards where required. Develop and maintain the Data Management Plan (DMP), the Data Validation Plan, and the eCRF Completion Guidelines. Define data handling, data transfer, reconciliation, and data security processes in compliance with applicable data protection requirements (e.g., GDPR and the Swiss FADP). Develop Edit Check Specifications and automated validation rules. Support database configuration and testing. Lead or coordinate User Acceptance Testing (UAT) of the Electronic Data Capture (EDC) system. Ensure database readiness and documented approval prior to study go-live. Train investigators and site staff on eCRF completion and EDC use, and support kick-off and investigator meetings as required. 2. Study Conduct and Data Cleaning Monitor incoming clinical trial data for completeness, consistency, and quality. Review data listings and identify missing, inconsistent, or implausible data. Generate, review, and track data queries to clinical trial sites. Use R programming to support data cleaning, validation, and preparation o…