Clinical Device Data Specialist (Hybrid)

Insulet Corporation•San Diego, MA

4d•Hybrid

About The Position

The Clinical Device Data Specialist is responsible for ensuring the quality and integrity of device data and other data collected as part of a clinical study. Responsibilities: · Understand the device data collected as part of clinical studies (pre and post market) and manage the data ensuring compliance with protocol, regulatory, GDPR and HIPAA requirements. · Conduct regular reviews of device data to ensure quality and integrity and follow issues from identification through resolution. · Support the development of clinical study databases and conduct data reviews including query generation/closure. · Support device management including ordering, shipping, returns, tracking and forecasting as needed. · Develop 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 well 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

Requirements

Bachelor’s degree and/or an equivalent combination of education or experience
Minimum of 3+ years of clinical data and/or research experience
Able to prioritize workload, assign realistic completion dates, and complete assignments on schedule.
Able to work in a high paced, changing environment and participate with other departments to achieve company goals.
Excellent written and oral communications skills required.
Proficiency in Microsoft Word and Excel required.
Working knowledge of Good Clinical Practices (GCP), ISO, FDA regulations including 21 CFR part 11, and current industry practices related to the conduct of clinical trials, 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.

Nice To Haves

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

Responsibilities

Understand the device data collected as part of clinical studies (pre and post market) and manage the data ensuring compliance with protocol, regulatory, GDPR and HIPAA requirements.
Conduct regular reviews of device data to ensure quality and integrity and follow issues from identification through resolution.
Support the development of clinical study databases and conduct data reviews including query generation/closure.
Support device management including ordering, shipping, returns, tracking and forecasting as needed.
Develop 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 well as applicable regulatory requirements (e.g. federal/country and local).
Performs other duties as required.