Sr Clinical Data Manager
Dexcom, Inc

Job Info

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About Dexcom:

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.

Summary:

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:

• 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.

Experience and Education Requirements:

• 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:

• 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.

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 talentacquisition@dexcom.com.

To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications.

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