Job Informationen

Your tasks: Support remote patient data monitoring workflows and data processing: work on processes, software, and infrastructure to handle data collected Develop review tools for patient data monitoring and provide regular outputs to clients as per Central Clinical Monitoring Plan Develop Database: design, create, maintain and close project and trial capture databases using paper and EDC systems Develop and maintain data standards (CDISC), manage ad hoc and standard reporting, develop and maintain internal documentation. Program data extractions, data listings for data cleaning purposes, logical checks, protocol violations, according to specifications provided by the TRIAL DATA MANAGER and in line with the quality standards Implement, execute, schedule procedures to manage CRF and non-CRF data Test the clinical databases and validation procedures Keep track of data management status activities on different studies Contribute to developing and implementing new technologies Assist in programming activities for Regulatory Submission (FDA filing) and Audit Requirements. Your profile: University degree (or equivalent) in mathematics, informatics, engineering or related disciplines or high school qualification At least 3 years’ experience in programming of which at least one in a data management function of a pharmaceutical company or a clinical research organization Good knowledge of programming languages and knowledge of data management principles and tools Experience with CTMS and understanding of LAB and other third-party data Experience and understanding of CDISC/SDTM standards Experience with Clinical Data Management System, including: - EDC Database build, Validations/Derivations, Coding, Discrepancy Database/Querying - Standardization modules, data reporting tools - Develop/maintain global data standards, CDISC/STDM mapping Knowledge of international clinical research regulations and requirements (e.g. ICH/GCP) and 21 CFR Part 11 Proficient in Microsoft Windows and Office Sound knowledge of clinical trial process Experience in maintaining and supporting data management and biostatistics processes in a distributed client base within a regulated environment Ability to communicate effectively in English (verbal and written) ,and to work in an agile way Act as a Team player

Benötigte Skills

• Mathematik
• Windows 10
• MS-Office
• Pharma