O pozici
Overview 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.
Co budeš dělat
- 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.
- 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
Koho hledáme
- 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 manag
- Strong attention to detail and excellent organizational skills
- Strong interpersonal, communication, and problem‑solving abilities, with the capacity to recognize issues and escalate 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)
Benefity
- 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.
