Senior Clinical Data Manager – Trials & Data Quality

IQVIA; Durham (NC); On-site; USD 69,000 - 171,000; Full time

Job summary

IQVIA is a leading global provider of clinical research services. The Clinical Data Manager performs activities for Phase I-III trials in line with ICH/GCP, ensuring data management from a data perspective is timely, within budget, and of high quality.

The role includes communicating data metrics, writing CDM documents, participating in UAT/QC, working with programmers on data flow, training site staff, reviewing data, and archiving trials while maintaining GCP compliance.

Qualifications

• Minimum of 5 years of data management experience.
• Bachelor's degree or allied health certification; commensurate experience considered.
• Experience with Electronic Data Capture (EDC) systems.
• Experience with Oracle Inform EDC preferred.
• Oncology and/or inflammatory therapeutic area experience preferred.
• Project management experience in Data Management preferred.
• CRO or CRO management experience preferred.

Responsibilities

• Communicate key clinical data management metrics with study team and determine actions.
• Review, develop and/or write CDM documents including CRFs, edit checks, and DMPs.
• Participate in UAT and Quality Control as needed.
• Collaborate with data programming to develop data flow charts and import guidelines.
• Assist with site and third‑party vendor CDM training.
• Provide data review training to Sr. Clinical Data Coordinators.
• Perform data review and discrepancy resolution as needed.
• Archive trials and documentation after completion.
• Ensure adherence to GCP and applicable regulations.

Skills

Data management

EDC systems

Oracle Inform EDC

Oncology experience

Project management

CRO experience

Education

Bachelor's degree or allied health certification

Tools

Inform EDC

Job description

IQVIA is a leading global provider of clinical research services. The Clinical Data Manager performs activities for Phase I-III trials in line with ICH/GCP, ensuring data management from a data perspective is timely, within budget, and of high quality.

The role includes communicating data metrics, writing CDM documents, participating in UAT/QC, working with programmers on data flow, training site staff, reviewing data, and archiving trials while maintaining GCP compliance.