QC & Data Entry Manager: Lead Data Quality & Compliance

Celerion; Tempe (AZ); On-site; USD 70,000 - 100,000; Full time

Job summary

Celerion is seeking a Data QC/DE Supervisor in Tempe, AZ to manage data workflow through QC and Data Entry for studies, ensuring on-time, compliant deliverables.

You will lead staff, train, write SOPs, interact with sponsors, and drive process improvements while maintaining regulatory standards and timelines. The role includes coordinating study setup, QC of data, and presenting processes to sponsors and auditors.

Qualifications

• Bachelor’s degree in a related field is required.
• 1-2 years of supervisory or trainer/leader experience required.
• Knowledge of Good Clinical Data Management Practices, Medical Terminology, GCP, ICH Guidelines, and 21 CFR Part11 preferred
• Ability to adjust hours to meet workload priorities
• Strong process improvement skills and change management experience
• Clinical data experience preferred
• Equivalent education and experience will be consider

Responsibilities

• Responsible for managing the data workflow through Quality Control (QC) and Data Entry (DE) for studies, maintains timelines for client deliverables and ensures regulatory compliance.
• Requires interface with other departments and/or sites. Requires interface with Sponsors.
• Write QC and DE SOPs and Procedure guides and participate in SOP and Procedure Guide Reviews
• Create and track metrics associated with QC and DE responsibilities
• Present the QC processes to sponsors and auditors
• Lead Process Improvement initiatives to improve the quality of the source data
• Participate in regulatory inspections, audits and meet with Sponsors as required
• Monitor process efficiency and implement process improvement as needed, including data flow and identification of error trends and resolutions.

Skills

Supervisory experience

Process improvement

Critical thinking

Regulatory compliance knowledge

Data management

Communication skills

Education

Bachelor’s degree in a related field

Job description

Celerion is seeking a Data QC/DE Supervisor in Tempe, AZ to manage data workflow through QC and Data Entry for studies, ensuring on-time, compliant deliverables.

You will lead staff, train, write SOPs, interact with sponsors, and drive process improvements while maintaining regulatory standards and timelines. The role includes coordinating study setup, QC of data, and presenting processes to sponsors and auditors.