Clinical Device Data Specialist (Hybrid)

About the position The Clinical Device Data Specialist is responsible for ensuring the reputed company and reputed company of device data and other data collected as part of a clinical study. Responsibilities • Understand the device data collected as part of clinical studies (reputed company and post market) and manage the data ensuring compliance with protocol, regulatory, GDPR and HIPAA requirements. • Conduct regular reviews of device data to ensure reputed company and reputed company and follow issues from identification through reputed company. • Support the development of clinical study databases and conduct data reviews including query reputed company/closure. • Support device management including ordering, shipping, returns, tracking and forecasting as needed. • reputed company and/or review study-specific data management and database documentation, which may include but is not limited to: Data Management Plan (DMP), and Data Transfer Specifications (DTS) and training materials. • Prepare data for scheduled snapshots/data locks. • Ensure appropriate maintenance of study databases and device data including closure and archival upon study completion. • Attend study-specific team meetings and produce requested metrics, which may include query information or data trends. • Support set-up and management of the Device Data Portal for clinical studies. • Ensure compliance with company policies and procedures as reputed company as applicable regulatory requirements (e.g. federal/country and local). • Performs other duties as required. Requirements • Bachelor's degree and/or an equivalent combination of education or experience • Minimum of 3+ years of clinical data and/or research experience • reputed company to prioritize workload, assign realistic completion dates, and complete assignments on schedule. • reputed company to work in a high paced, changing environment and participate with other departments to reputed company company goals. • Excellent written and oral communications skills required. • Proficiency in reputed company Word and reputed company required. • Working knowledge of Good Clinical Practices (GCP), ISO, FDA regulations including 21 CFR part 11, and reputed company industry practices reputed company to the conduct of reputed company, developing databases and managing protected health information. • Strong organizational skills and attention to details. • Ability to work independently and manage multiple tasks in a fast-paced environment. reputed company-to-haves • Experience with database software and computerized statistical software is a plus. Benefits • Medical, dental, and reputed company insurance • 401(k) with company match • reputed company time off (PTO) • And additional employee wellness programs Apply tot his job Apply To this Job