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.
FUNCTIONAL DESCRIPTION: Professional Individual Contributor
Collaborates with various departments on the design, documentation, testing and implementation of clinical data studies. Develops systems for organizing data to analyze, identify and report trends. Analyzes the interrelationships of data and defines logical aspects of data sets. Prepares reports of clinical trial studies for internal validation and cross validation studies. May evaluate and resolve issues regarding contents of reports.
Responsible for all data management functions related to clinical conducted under Dexcom's Internal Clinical Study program.
Essential Duties and Responsibilities:
Designs subject case report forms for receiving, processing and tracking data
Develop study specific annotated CRFs, database documentation, edit
check specifications, data handling conventions and data entry instructions
Designs and validates clinical databases including designing or testing logic checks
Processes clinical data including receipt, entry, verification and filing of information
Generates data queries based on validation checks or errors or omissions identified during data entry to resolve identified problems.
Performs quality control audits to ensure accuracy, completeness, and proper use of clinical data system
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.
Summarizes basic elements for clinical databases periodically.
Communicates with end users to define or implement clinical data management requirement for the clinical study such as data release, delivery schedules, and testing protocols.
Writes sections of clinical study reports with assistance.
Provides training and technical support to clinical site personnel on EDC for specific studies.
Maintains more than 3 study databases and data management activities concurrently.
Ability to multi-task while still being detail oriented
Works with management or senior Data Associates to develop project-specific data management plans that address areas such as data reporting, transfer, database lock and work flow.
Works with management or senior Data Associates to write work instruction manuals, data capture guidelines, or standard operating procedures.
Monitors work quality to ensure compliance with standard operating procedures.
This position assumes and performs other duties as assigned.
Typically requires a Bachelor's degree in a technical discipline, and a minimum of 2-5 years related experience or Master's degree and 0-2 years' equivalent experience.
Possesses a high level of theoretical knowledge. Ability to deliver technical ideas that have an impact on the objectives. Understands organizational and functional processes and policies aligned to the technical and business goals.
Demonstrates technical proficiency. Works on moderately complex problems where analysis of situations or data requires evaluation. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Interprets data and draws conclusions regarding results used in presented material.
Exercises judgment within defined procedures and practices to determine appropriate action.
Normally receives general instructions on routine work, detailed instructions on new projects or assignments.
Supervisory Responsibilities This job has no supervisory responsibilities.