University of Utah Job Description
Job Summary
This position is primarily a study lead Clinical Data Manager. It supports multiple clinical study teams by reviewing and/or completing study related clinical data management deliverables. Frequently interacts with study team members to troubleshoot, manage, and develop study specific processes. Actively participates in the development of processes, and documents, that support the clinical data management team.
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 two or more years of relevant clinical data management experience. Understanding of basic regulations involving clinical trials, clinical data management, and clinical data systems. Ability to perform all data management activities associated with a clinical trial with a high degree of quality. Possess all skills, knowledge and competencies required of the CDM I position.
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 in the cross-functional project teams as the lead clinical data manager.
2. Provide input in the design of protocols, forms, and data collection processes.
3. Create and maintain the following study specific documents:
-Data Management Plans
-Edit specifications
-SAE Reconciliation Guidelines
-Other plans and guidelines as required
4. Ensure documents are provided according to established timelines and SOPs.
5. Communicate issues that affect timeline, deliverables, and/or data quality to the study team and functional supervisor.
6. Manage and document the study specific change control process and provide realistic feedback to the study team about impact of proposed changes.
7. Review and provide feedback on other study specific documents.
8. Manage all data management activities of a clinical trial in the maintenance phase of the project.
9. Provide project specific training on electronic data capture (EDC) and other data management systems to internal and external personnel.
Problem Solving
Employees in this position are required to discuss questions and suggestion for improvements with the study team prior to implementing new or modified study specific processes. The Clinical Data Manager II is expected to have a solid understanding of the regulatory framework as it relates to clinical research and data management, and be able to assess current and proposed processes for compliance with regulations and standards.
Comments
This position is intended to be focused on study level activities with oversight from the manager of clinical data management. Employees are expected to be the independent representative of the clinical data management function on the cross functional study team.
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.
