Clinical Data Manager 2
DexcomAbout the role
The Company
Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health.
We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us.
Meet the team:
The Clinical Data Manager will be responsible for all data management functions related to clinical conducted under Dexcom's Internal Clinical Study program.
Where you come in:
- You will design clinical trial specific subject Case Report Forms (CRFs) for use in e-clinical EDC systems
- You will develop study specific annotated CRFs, database documentation, edit check specifications, data handling conventions and data entry instructions.
- You will design and validate clinical databases including designing logic checks, YAT,etc.
- You have knowledge of MedDRA and WHODrug Coding.
- You will program SAS edit checks and SAS macros for data cleaning.
- You will process clinical data including receipt, entry, verification and filing of information.
- You will generate data queries based on validation checks or errors or omissions identified during data entry to resolve identified problems.
- You perform quality control audits to ensure accuracy, completeness, and proper use of clinical data systems.
- You are responsible for filing and maintaining CRFs, subject diaries, and other subject-specific documentation (e.g., Marketing questionnaires) collected during clinical studies. You are responsible for filing and maintaining digital data collected during clinical studies.
- You will summarize basic elements for clinical databases periodically.
- You will connect with end users to define or implement clinical data management requirements for the clinical study such as data release, delivery schedules, and testing protocols.
- You will write sections of clinical study reports with assistance.
- You provide training and technical support to clinical site personnel on EDC for specific studies.
- You will maintain more than 3 study databases and data management activities concurrently.
- You have the ability to multi-task while still being detail oriented.
- You develop project-specific data management plans that address areas such as data reporting, transfer, database lock and workflow.
- You will monitor work quality to ensure compliance with standard operating procedures. This position assumes and performs other duties as assigned.
Experience and Education Requirements:
- Typically requires a Bachelor's degree in a technical discipline, and a minimum 2-5 years related experience or Master's degree and 0-2 years equivalent experience.
What you’ll get:
- A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community.
- A full and comprehensive benefits program.
- Growth opportunities on a global scale!
- Access to career development through in-house learning programs and/or qualified tuition reimbursement.
- An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.
Travel Required:
- 15-25%
Remote Workplace: Your location will be a home office; you are not required to live within commuting distance of your assigned Dexcom site (typically 75 miles/120km). If you reside within commuting distance of a Dexcom site (typically 75 miles/120km) a hybrid working environment may be available. Ask about our Flex workplace option.
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