University of Utah Job Description
This is a functional team and study team lead clinical data management position. It supports the clinical data management function and reports to the Manager of Clinical Data Management. The Clinical Data Manager IV is a senior team member of the clinical data management functional group. This position is responsible for assessing data management resources, and mentoring other team members. This position must have expertise and be the subject matter expert on one or more specific areas of data management (i.e. systems validation, standardization implementation etc).
Master’s level degree in Bioinformatics, Statistics, Clinical Research, or related subject, and six years relevant clinical data management experience or equivalency (one year of education can be substituted for two years of related work experience). Possess and maintain a strong working knowledge of the conduct and regulations involving clinical trials, clinical data management, and clinical data systems. Operate independently in areas of clinical data management. Possess all skills, knowledge and competencies required of the CDM I, CDM II and CDM III positions.
Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.
This job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
1. Work with the Manager of Clinical Data Management to assist in building functional infrastructure, and implement processes that improve the efficiency, and organization of clinical data management
2. Train and mentor junior Clinical Data Mangers, including oversight and review of study deliverables. Must be able to share expertise within the functional group and provide support as needed.
3. Evaluate clinical data systems and suggest improvement and/or new systems to vendors and the Manager of Clinical Data Management.
4. Assume authority and perform functions of the Manager of Clinical Data Management in their absence.
The Clinical Data Manager VI is expected to have a solid understanding of the regulatory framework as it relates to the systems and processes used. Ability to provide accurate assessment of the data management resources required for concept clinical trials based on minimal information. Ability to function independently and when required provides expert level guidance and leadership to study and functional teams.
This position will be expected to actively develop the skills and expertise of the clinical data management team. This will be accomplished by identifying key areas for improvement for both individuals and the team. Will assist in the coordination and management of the hiring process. The CDM IV is expected to actively seek out leadership opportunities.
Work Environment and Level of Frequency typically required
Nearly Continuously: Office environment.
Physical Requirements and Level of Frequency that may be required
Nearly Continuously: Sitting, hearing, listening, talking.
Often: Repetitive hand motion (such as typing), walking.
Seldom: Bending, reaching overhead.
250 East 200 South, Suite 125,
Salt Lake City, Utah 84111
Phone: 801.581.2169 Email: AskHR@utah.edu
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