Remote - Senior Clinical Data Analyst - Medical Device

A highly reputable medical device corporation is currently hiring a Senior Clinical Data Analyst to work remotely in the United States.

Job Description:

• Designs clinical trial specific subject Case Report Forms for use in e-clinical EDC systems.
• Develops study specific annotated CRFs, database documentation, edit check specifications, data handling conventions and data entry instructions.
• Designs and validates clinical databases including designing logic checks, UAT etc.
• Knowledge of MedDRA and WHODrug Coding.
• Programs SAS edit checks and SAS macros for data cleaning.
• 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 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.
• 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.
• Develops project-specific data management plans that address areas such as data reporting, transfer, database lock and work flow.
• Monitors work quality to ensure compliance with standard operating procedures.

Required Skills:

• Bachelor’s degree in a technical discipline, and a minimum of 5 plus years related experience or Master’s degree and 2 plus years equivalent industry experience or a PhD and 1 plus years of experience.
• Develops study specific CRF
• Programs SAS edit checks and SAS macros OR Strong EDC building experience
• Designs and validates clinical databases