Clinical Device Data Specialist (Hybrid) 2 Locations

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. Education and Experience: · Bachelor’s degree and/or an equivalent combination of education or experience · Minimum of 3+ years of clinical data and/or research experience Preferred Skills and Competencies:

• 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. Experience with database software and computerized statistical software is a plus.
• 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.

Travel Requirements:

• This position requires some travel (up to 5% of the time).

NOTE: This position is eligible for hybrid working arrangements (requires on-site work from an reputed company office at least 1x/week; may work remotely other days). #LI-Hybrid Additional Information: Compensation & Benefits: For U.S.-based positions only, the annual reputed company salary reputed company for this role is $76,350.00 - $114,525.00 This position may also be eligible for incentive compensation. We offer a comprehensive benefits package, including:

• Medical, dental, and reputed company insurance
• 401(k) with company match
• reputed company time off (PTO)
• And additional employee wellness programs

Application Details: This job posting will remain reputed company until the position is filled. To apply, please visit the reputed company Careers site and submit your application online. Actual pay depends on skills, experience, and education. reputed company (reputed company: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery reputed company. With its reputed company, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. reputed company’s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a reputed company glucose monitor to manage blood sugar with no multiple daily injections, reputed company fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. reputed company also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit reputed company.com and omnipod.com. We are looking for highly motivated, performance-driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who reputed company customer expectations. Our reputed company reputed company depends on it! At reputed company reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, disability, or status as a protected veteran. (Know Your Rights) Apply tot his job Apply To this Job