Übersicht
Selution, in partnership with Cordis, 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 healthcare by creating next-generation solutions that address unmet and critical medical needs.
Verantwortungsbereiche
This remote-based EU position plays an important role in the success of SELUTION clinical trials and contributes to improving patient care by ensuring the quality 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 day‑to‑day data management activities to ensure high-quality, 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 external partners to help maintain accurate and complete study data.
Key Responsibilities
Provide day‑to‑day 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 timely, compliant, inspection‑ready, and high‑quality data to support analyses, submissions, and data‑driven decisions
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 Form (CRF) development, including CRF specifications and CRF completion guidelines
Support database programming tasks by: creating, testing, and implementing electronic data capture (EDC) 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 check document, issue logs, UAT summary report
Help maintain the study database throughout lifecycle of study, including managing users access requests, and supporting database updates
Prepare reports/trackers within the database to support data review and study oversight
Perform routine data cleaning and validation to ensure consistency, integrity and accuracy based on project specific guidelines and protocol requirements
Assist in creating data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audit
Provide input into clinical research documents (e.g. Protocols and Statistical analysis plans)
Support oversight of CROs and provide feedback related to the data management operations, issues and trends in performance
Provide database exports as applicable
Support the archival process for study databases and related documents
Coordinate routine communication with database vendors, escalating technical or operational issues to the Clinical Data Manager as appropriate
Strategic Impact
This role contributes to the data integrity and reliability of clinical trial data by supporting the Clinical Data Manager in delivering high-quality data to support clinical study analyses and regulatory submissions.
Key Interactions
Supervisor: Clinical Data Manager (with functional oversight from Sr. Director, Clinical Operations).
Internal Interactions: This role will interact heavily with Clinical Study Management teams across all projects, Biostatistics, Safety, Regulatory, and cross‑functionally as needed.
External Customer Interactions: This role will work with CROs, EDC vendors, physicians and clinical research teams.
Qualifikationen
Required Experience
Global pre‑market and post‑market medical device clinical study experience is required.
Bachelor’s 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 pre‑market and post‑market studies (including US IDE trials)
Experience as database programmer
Competencies & Skills
Precise, Rigorous, Detail‑Oriented
Outstanding verbal and written communication skills, in addition to excellent organizational skills
Strong interpersonal skills, with the ability to collaborate effectively and maintain professional interactions. Problem‑solving abilities, with the capacity to recognize issues and elevate them appropriately to the Clinical Data Manager. Supportive team member, keen to promote quality through example and continuous support
Team‑oriented mindset, demonstrating reliability and a positive approach to supporting group goals
Ability to thrive in a fast‑paced environment while remaining flexible, proactive, resourceful and efficient
Knowledgeable in ICH GCP guidelines and industry standards applicable to data capture and data management process to ensure the appropriate conduct of clinical studies
Familiarity in Power BI, Smartsheet, or other data/dashboard tools
Comfortable working in an international environment, with an appreciation for global clinical trial operations
Fluent in English (additional languages are beneficial)
Cordis is proud to be an equal opportunity employer and is committed to providing equal opportunity for all teammates and applicants. At Cordis, our teammates all bring different strengths, experiences, and backgrounds, who share a passion for improving people's lives. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one’s identity. All our teammates’ points of view are key to our success, and we believe inclusion is everyone's responsibility. Together, we strive to create and maintain working and learning environments that are inclusive, equitable and welcoming.
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