Clinical Data Manager III

The University of Utah • Salt Lake, UT

7d • Onsite

About The Position

This position is primarily a study / team lead Clinical Data Manager. It supports multiple clinical study teams by ensuring all study related clinical data management deliverables are completed with a high degree of quality and within timelines. Participates in and/or leads the cross-functional study team as the clinical data management knowledge expert. This position is contingent based upon continued funding and may be temporary.

Requirements

• Bachelor’s degree in the life sciences, pharmacy, nursing, a related subject, or equivalency (one year of education can be substituted for two years of related work experience).
• Requires five or more years of relevant clinical data management experience.
• Possess in-depth understanding of the conduct and regulations involving clinical trials, clinical data management, and clinical data systems, such as Federal ( FDA ) regulations and requirements governing the conduct of clinical trials including, but not limited to, GCP and ICH requirements.
• Possess in-depth knowledge and understanding of all data management systems and data handling procedures.
• Demonstrated ability to independently perform all data management activities associated with a clinical trial with minimal oversight and a high degree of quality.
• Possess all skills, knowledge and competencies required of the CDM I, and CDM II positions.

Responsibilities

• Participate or lead the cross-functional project team as the clinical data management knowledge expert.
• Contribute to the design of protocols, forms, and data collection processes.
• Troubleshoot and implement solutions to issues that arise during the development, management and close out of clinical studies.
• Develop timeline for clinical data management deliverables, and ensure they are completed.
• Manage and/or complete all study level data management activities with a high degree of quality.
• Work with the Manager of CDM to create, modify and implement data management processes.
• Provide in-house expertise on data management related technical subject matter. (i.e. CDISC , 21 CFR Part 11, Systems validation, etc.)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees