Clinical Data Manager 2

6 days ago

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Dexcom

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Continuous Glucose Monitoring • Medical Devices • Diabetes • Decision Support • Data

10,000+ employees

Founded 1999

⚕️ Healthcare Insurance

🧬 Biotechnology

Description

• Responsible for all data management functions related to clinical conducted under Dexcom's Internal Clinical Study program. • Design clinical trial specific subject Case Report Forms (CRFs) for use in e-clinical EDC systems. • Develop study specific annotated CRFs, database documentation, edit check specifications, data handling conventions and data entry instructions. • Design and validate clinical databases including designing logic checks, YAT, etc. • Knowledge of MedDRA and WHODrug Coding. • Program SAS edit checks and SAS macros for data cleaning. • Process clinical data including receipt, entry, verification and filing of information. • Generate data queries based on validation checks or errors or omissions identified during data entry to resolve identified problems. • Perform quality control audits to ensure accuracy, completeness, and proper use of clinical data systems. • Responsible for filing and maintaining CRFs, subject diaries, and other subject-specific documentation (e.g., Marketing questionnaires) collected during clinical studies. • Summarize basic elements for clinical databases periodically. • 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. • Write sections of clinical study reports with assistance. • Provide training and technical support to clinical site personnel on EDC for specific studies. • Maintain more than 3 study databases and data management activities concurrently. • Develop project-specific data management plans that address areas such as data reporting, transfer, database lock and workflow. • Monitor work quality to ensure compliance with standard operating procedures.

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.

Benefits

• 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.