University of Utah Job Description
Job Summary
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.
Qualifications
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.
Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.
Disclaimer
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.
Essential Functions
1. Participate or lead the cross-functional project team as the clinical data management knowledge expert.
2. Contribute to the design of protocols, forms, and data collection processes.
3. Troubleshoot and implement solutions to issues that arise during the development, management and close out of clinical studies.
4. Develop timeline for clinical data management deliverables, and ensure they are completed.
5. Manage and/or complete all study level data management activities with a high degree of quality.
6. Work with the Manager of CDM to create, modify and implement data management processes.
7. Provide in-house expertise on data management related technical subject matter. (i.e. CDISC, 21 CFR Part 11, Systems validation, etc.)
Problem Solving
Employees in this position are encouraged to develop and suggest new data management processes and workflow that improve and support the study team. The Clinical Data Manager III is expected to have an in-depth understanding of the regulatory framework as it relates to clinical data management and be able to assess current and proposed processes for compliance with regulations and standards. Successful CDM IIIs have the ability to provide accurate assessments of data management resource requirements for ongoing clinical studies.
Comments
This position is intended to be focused on study level activities. Employees are expected to be a subject matter expert of clinical data management function and actively participate in data management and study team meeting. Will assist in development of data management SOPs, processes and procedures.
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.
