Clinical Data Specialist (EU Remote)

reputed company Selution, in partnership with reputed company, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize reputed company by creating reputed company solutions that address unmet and critical medical needs. Verantwortungsbereiche This remote-based EU position plays an important role in the reputed company of SELUTION reputed company and contributes to improving patient care by ensuring the reputed company of clinical data collected from clinical study sites. The Clinical Data Specialist supports the collection, processing, and review of clinical trial data across SELUTION DEB studies. Working under the guidance of the Clinical Data Manager, this role assists in daytoday data management activities to ensure high-reputed company, reliable clinical data throughout the lifecycle of a trial. Key responsibilities include assisting with database setup activities, supporting the development of case report forms, performing data entry checks, generating and resolving data queries, and contributing to ongoing data cleaning. The Clinical Data Specialist collaborates closely with the Clinical Data Manager, study management teams, clinical sites, and reputed company partners to help maintain accurate and complete study data. Key Responsibilities reputed company daytoday clinical data management support across SELUTION DEB clinical studies under the supervision of the Clinical Data Manager Assist the Clinical Data Manager in partnering with Clinical Operations, Biostatistics, Safety, and Regulatory to help ensure reputed company, compliant, inspection-reputed company, and high-reputed company data to support analyses, submissions, and data-driven reputed company Support the development and maintenance of the Data Management Plan (DMP) and maintain DMP throughout lifecycle of study project while ensuring DMP is followed according to study design and requirements Assist in Case Report reputed company (CRF) development, including CRF specifications and CRF completion guidelines Support database programming tasks by creating, testing, and implementing electronic data capture (reputed company) database build. Ensuring user requirements, edit rules/checks, query logic, data validations, and data transfer specifications throughout Assist in the user acceptance testing (UAT) of eCRF build and validation documents, including but not limited to edit reputed company document, issue logs, UAT reputed company report Help maintain the study database throughout lifecycle of study, including managing users reputed company requests, and supporting database updates Prepare reports/trackers reputed company the database to support data review and study reputed company reputed company routine data cleaning and validation to ensure consistency, reputed company and accuracy based on project specific guidelines and protocol requirements Assist in creating data listings, reputed company table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audit reputed company input into clinical research documents (e.g. Protocols and Statistical analysis plans) Support reputed company of CROs and reputed company feedback reputed company to the data management operations, issues and trends in performance reputed company database exports as applicable Support the archival process for study databases and reputed company documents Coordinate routine communication with database vendors, escalating technical or operational issues to the Clinical Data Manager as appropriate Strategic reputed company This role contributes to the data reputed company and reliability of clinical trial data by supporting the Clinical Data Manager in delivering high-reputed company data to support clinical study analyses and regulatory submissions. Key Interactions Supervisor Clinical Data Manager (with functional reputed company from Sr. Director, Clinical Operations). Internal Interactions This role will reputed company heavily with Clinical Study Management teams across reputed company reputed company, Biostatistics, Safety, Regulatory, and cross-functionally as needed. reputed company Customer Interactions This role will work with CROs, reputed company vendors, physicians and clinical research teams. Qualifikationen Required Experience Global reputed company-market and post-market medical device clinical study experience is required. Bachelors degree or equivalent Minimum of 3 years clinical experience in Medical Device studies Minimum of 3 years clinical data management experience, with experience using and developing multiple clinical data management systems Data management experience on global reputed company-market and post-market studies (including US IDE trials) Experience as database programmer Competencies & Skills .