Remote - Clinical Data Manager - Level Ii

A highly reputable medical device corporation is currently hiring a Remote Clinical Data Manager - Level II to work remotely in the United States.

Summary:

• Responsible for clinical 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

• Develops study specific annotated CRFs, database documentation, edit check specifications, data handling conventions and data entry instructions.
• Provides input in study protocol design related to data collection and data management.
• Write SAS programs to generate tables and listings to facilitate 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.
• Ensures that each clinical study database is designed in accordance with the database definitions outlines in the DMP.
• Reconciles device issues, adverse events and serious adverse events.
• Coordinates and completes data management activities to meet project timelines.
• Other duties as assigned
• Assists in clinical study CRF related summary and listing reports using related software.
• Responsible for filing and maintaining digital data (e.g. client device downloads and blood glucose meter downloads) collected during clinical studies.
• Program SAS edit checks and SAS macros for data cleaning.
• Provides guidance and mentorship to less experienced and/or entry-level Associates of Clinical Data Management.
• Responsible for filing and maintaining CRFs, subject diaries, and other subject-specific documentation (e.g. Marketing Questionnaires) collected during clinical studies.
• Maintains 4-5 study databases and data management activities concurrently.

Experience and Education Requirements:

• Typically requires a Bachelor's degree in a technical discipline, and a minimum of 5 plus ears related experience OR a Master's degree with 3 plus years of equivalent industry experience

Preferred Qualifications:

• High level expertise in EDC systems.
• Certified Clinical Data Manager, SAS certification, knowledge in SQL or any other programming languages.
• A minimum of 5+ years of related experience in data management or related fields in clinical studies.