Dexcom, Inc. empowers people to take control of diabetes through innovative continuous glucose monitoring (CGM)systems. Headquartered in San Diego, California, Dexcom has emerged as a leader of diabetes care technology. By listening to the needs of users, caregivers, and providers, Dexcom simplifies and improves diabetes management around the world.
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.
Essential Duties AND Responsibilities
Experience and Education Requirements:
- 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 outlines in the DMP.
- Develops study specific annotated CRFs, database documentation, edit check specifications, data handling conventions and data entry instructions.
- Program SAS edit checks and SAS macros for data cleaning.
- 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 device downloads and blood glucose meter downloads) collected during clinical studies.
- Write SAS programs to generate tables and listings to facilitate data cleaning.
- 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 with 2-5 years of equivalent industry experience OR a PhD with 0-2 years experience. Preferred Qualifications:
Travel Requirement:Functional Description
- A minimum of 5+ years of related experience in data management or related fields in clinical studies.
- High level expertise in EDC systems.
- Certified Clinical Data Manager, SAS certification, knowledge in SQL or any other programming languages.
Provides primary input to clinical trial protocol design related to optimal methods of clinical data collection, device data flow, data flow mapping and use of e-clinical digital platform systems. Designs clinical trial specific subject Case Report Forms and designs, deploys and manages clinical databases for clinical trials. Develops Data Management Plans (DMPs) and CRF completion guidelines (CCG) development. Designs and programs SAS edit check specifications. Generates data queries based on validation checks, errors, or omissions identified prior to database lock to resolve identified problems.Functional/Business Knowledge
- Possesses broad understanding of technical principles and theories. Ability to synthesize external data and research findings for application that may impact technical objectives.
- Demonstrates successes in technical proficiency and independent thought. Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
ManagementField SalesExperience and Education
- 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.
- Typically requires a Bachelors degree in a technical discipline, and a minimum of 5-8 years related experience or Masters degree and 2-5 years equivalent industry experience or a PhD and 0-2 years experience.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Talent Acquisition at firstname.lastname@example.org.
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