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Job Overview

The Sr. Clinical Data Coordinator performs activities related to the conduct of Phase I – III clinical trials in accordance with ICH/Good Clinical Practices (GCP) and other relevant procedures and guidelines. This role ensures that quality work products are produced, and timelines and deliverables are met. This position can typically be a support lead role with 3 to 5 years of Clinical Data Management (CDM) experience, particularly with Oracle and Inform tools.

Essential Functions

• Perform ongoing data review, including reconciliation of third-party data streams and serious adverse event (SAE) reconciliation with the safety database.

• Conduct User Acceptance Testing (UAT) of clinical databases.

• Perform Quality Control (QC) of clinical databases.

• Update Data Management-related documentation as needed.

• Work independently on discrepancy management and listings review.

• Send Data Management (DM) metrics to the trial team.

• Handle third-party data reconciliations such as Lab, PK, IRT, and SAE recon.

• Participate in startup activities, mainly in conduct and close-out activities.

Qualifications

• Bachelor’s degree

• Minimum of 3 years of data management experience is required.

• Experience with Electronic Data Capture (EDC) systems is required.

• Experience with Oracle Inc.'s Inform™ EDC system is preferred.

• Oncology and/or inflammatory therapeutic area experience is preferred.

• Experience in working independently on discrepancy management, listings review, and handling third-party data reconciliations.

• Experience in startup activities, particularly in conduct and close-out phases, is preferred

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IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com