Clinical Data Lead, Trial Management

Utah; Salt Lake City (UT); On-site; USD 40,000 - 91,000; Full time

Job summary

Huntsman Cancer Institute in Salt Lake City, UT seeks a Clinical Data Manager II to lead data management for multiple clinical studies and support cross-functional teams.

Responsibilities include protocol/form design, document creation, adherence to timelines/SOPs, change control, data quality oversight, and staff training on data systems. This is a patient-sensitive role with CDC-immunization requirements.

Qualifications

• Equivalency statement: 1 year of higher education can be substituted for 1 year of directly related work experience
• Department may hire at: Clinical Data Manager II requires a bachelor’s (or equivalency) + 4 years or a master’s (or equivalency) + 2 years of directly related work experience
• Preferences: Bachelor’s degree in life sciences, two+ years of relevant clinical data management experience; understanding of basic regulations involving clinical trials, data management, and systems

Responsibilities

• Participate in cross-functional project teams as the lead clinical data manager.
• Provide input in the design of protocols, forms, and data collection processes.
• Create and maintain study documents: Data Management Plans, Edit specifications, SAE Reconciliation Guidelines, other plans and guidelines as required.
• Ensure documents are provided according to timelines and SOPs.
• Communicate issues affecting timeline, deliverables, or data quality to study team and supervisor.
• Manage change control processes and provide feedback on impact of changes.
• Review and provide feedback on study documents.
• Manage all data management activities of a clinical trial in the maintenance phase.
• Provide training on electronic data capture (EDC) and other data management systems.

Skills

Cross-functional collaboration

Regulatory awareness

Data management

Project coordination

Training others

Education

Bachelor’s degree in life sciences or related

Tools

EDC systems

Job description

Huntsman Cancer Institute in Salt Lake City, UT seeks a Clinical Data Manager II to lead data management for multiple clinical studies and support cross-functional teams.

Responsibilities include protocol/form design, document creation, adherence to timelines/SOPs, change control, data quality oversight, and staff training on data systems. This is a patient-sensitive role with CDC-immunization requirements.