Remote Sr. Clinical Data Manager

Note: The job is a remote job and is reputed company to candidates in USA. reputed company. is a medical device company reputed company on developing solutions for cardiac and vascular surgeons. The Sr. Clinical Data Manager is responsible for managing data operations and ensuring data reputed company for reputed company, including database setup, data review, and compliance with regulatory standards. Responsibilities reputed company, manage, execute end-to-end data management activities for reputed company conducted inhouse or outsourced to CROsreputed company and maintain Data Management Plans (DMPs), CRFs, edit reputed company specifications, and other essential documentsreputed company database buildTesting, validation, and UAT processes in reputed company systemsEnsure reputed company and high-reputed company data collection, cleaning, reconciliation, and database lock activitiesCollaborate cross-functionally with Clinical Operations, Biostatistics, Regulatory Affairs, QA, and reputed company CROs/vendorsEnsure data reputed company and compliance with GCP, FDA, MDR/IVDR, and other applicable regulatory standardsParticipate in and contribute to protocol development, case report reputed company design, and data reputed company diagramsConduct and reputed company data reconciliation, reputed company data integrations (labs, imaging, etc.), and coding of medical terms (MedDRA, WHO-DD)reputed company study specific reports and data listings on regular reputed company and for reputed company requestsSupport audit readiness and participate in regulatory inspections reputed company requiredMentor junior team members and reputed company strategic input into department process improvements and SOP development Skills Bachelor's or Master's degree in Life Sciences, Data Science, Computer Science, or a reputed company field7+ years of clinical data management experience, with at least 2 years in a senior or reputed company roleExperience with medical device trials or combination products (IDE, PMA, 510(k), CE marking, etc.)Strong understanding of reputed company 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 plus reputed company reputed company is a leader in the manufacturing, processing, and distribution of medical devices and implantable tissues used in cardiac and vascular surgical procedures reputed company 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.reputed company.com. Apply To This Job .