[Remote] Sr. Clinical Data Manager

Note: The job is a remote job and is open to candidates in USA. Artivion, Inc. is a medical device company focused on developing solutions for cardiac and vascular surgeons. The Sr. Clinical Data Manager is responsible for managing data operations and ensuring data integrity for clinical trials, including database setup, data review, and compliance with regulatory standards.ResponsibilitiesLead, manage, execute end-to-end data management activities for clinical trials conducted inhouse or outsourced to CRO’sDevelop and maintain Data Management Plans (DMPs), CRFs, edit check specifications, and other essential documentsOversee database buildTesting, validation, and UAT processes in EDC systemsEnsure timely and high-quality data collection, cleaning, reconciliation, and database lock activitiesCollaborate cross-functionally with Clinical Operations, Biostatistics, Regulatory Affairs, QA, and external CROs/vendorsEnsure data integrity and compliance with GCP, FDA, MDR/IVDR, and other applicable regulatory standardsParticipate in and contribute to protocol development, case report form design, and data flow diagramsConduct and oversee data reconciliation, external data integrations (labs, imaging, etc.), and coding of medical terms (MedDRA, WHO-DD)Provide study specific reports and data listings on regular basis and for ad-hoc requestsSupport audit readiness and participate in regulatory inspections when requiredMentor junior team members and provide strategic input into department process improvements and SOP developmentSkillsBachelor's or Master's degree in Life Sciences, Data Science, Computer Science, or a related field7+ years of clinical data management experience, with at least 2 years in a senior or lead roleExperience with medical device trials or combination products (IDE, PMA, 510(k), CE marking, etc.)Strong understanding of EDC systems and data standards (CDASH, SDTM, CDISC)Knowledge of regulatory requirements (FDA, EMA, ISO 14155, GCP, GDPR)Excellent organizational, leadership, and communication skillsExperience working in an FDA-regulated and/or ISO-certified environmentAdvanced proficiency in data visualization tools and data analytics platforms (such as Python and/or R) is a plusCompany OverviewArtivion is a leader in the manufacturing, processing, and distribution of medical devices and implantable tissues used in cardiac and vascular surgical procedures focused on aortic repair. It was founded in 1984, and is headquartered in Kennesaw, GA, US, with a workforce of 1001-5000 employees. Its website is http://www.artivion.com.