Founded in 1999, Dexcom, Inc. provides continuous glucose monitoring technology to help patients and their clinicians better manage diabetes. Since our inception, we have focused on better outcomes for patients, caregivers, and clinicians by delivering solutions for people with diabetes - while empowering our community to take control of diabetes.
Responsible for data management activities including, but not limited to, developing data management plans, department SOPs, supervising and performing database development, testing, validation, reviewing and processing clinical trial data to ensure the completeness, accuracy and consistency of clinical trials databases.
Functional Description: Professional Individual Contributor
Collaborates with various departments on the design, documentation, testing and implementation of clinical data studies. Develops electronic database systems (EDC) for collecting and organizing data to analyze, identify and report trends. Analyzes the interrelationships of data to define logical aspects of datasets. May evaluate and resolve issues regarding contents of reports.
Possesses broad understanding of technical principles and theories. Ability to synthesize external data and research findings for application that may impact technical objectives.
Essential Duties AND Responsibilities
Provides input in study protocol design related to data collection and data management.
Ensures that each clinical study database is designed in accordance with the database definitions outlined in the DMP
Develops study specific annotated CRFs, database documentation, edit check specifications, data handling conventions and data entry instructions
Performs all data management activities with no or minimal supervision, including but not limited to database development, testing, validation, site training and support, query resolution, audit, lock, and archive
Coordinates and completes data management activities to meet project timelines
Reconciles device issues, adverse events and serious adverse events
Maintains more than 4-5 study databases and data management activities concurrently
Responsible for filing and maintaining CRFs, subject diaries, and other subject-specific documentation (e.g., Marketing questionnaires) collected during clinical studies
Responsible for filing and maintaining digital data (e.g., Dexcom Receiver downloads, and blood glucose meter downloads) collected during clinical studies
Assists in clinical study CRF related summary and listing reports using related software
Provides guidance and mentorship to less experienced and/or entry-level Associates of Clinical Data Management
Other duties as assigned.
Typically requires a Bachelor's degree in a technical discipline, and a minimum of 5-8 years related experience or Master's degree and 2-5 years equivalent industry experience.
A minimum of 5+ years of related experience in data management or related fields in clinical studies are required. High level expertise in EDC systems is required. Experience working with eClinical (i.e. eConsent and eSource) is preferred. Certified Clinical Data Manager, SAS certification, knowledge in SQL or any other programing languages is highly desired.
Receives general oversight and guidance on approaches to compete project related tasks.
Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors. Develops solutions to a variety of problems. Builds productive internal/external working relationships.
Exercises good judgment in selecting methods and techniques for obtaining solutions.
Normally receives little instruction on day-to-day work, general instructions on new assignments.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is frequently required to sit. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; and talk or hear. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, and ability to adjust focus.