Clinical Data Lead – Trials & QC

JobDiva, Inc.; Wilmington (DE); On-site; USD 85,000 - 110,000; Full time

Job summary

Kaztronix is seeking a Sr. Clinical Data Coordinator to support Phase I-III trials in accordance with ICH/GCP. The role emphasizes data review, UAT of clinical databases, QC activities, and maintaining Data Management documentation to ensure quality deliverables and timelines.

The candidate should have a bachelor’s degree or allied health certification, at least 3 years of data management experience, and experience with EDC systems. Oncology or inflammatory disease experience is preferred.

Qualifications

• Bachelor's degree or allied health certification from an accredited institution.
• Minimum of 3 years of data management experience.
• Experience with Electronic Data Capture (EDC) systems is required.
• Experience with Oracle InformTM EDC system is preferred.
• Oncology and/or inflammatory therapeutic area experience is preferred.

Responsibilities

• Perform ongoing data review, including reconciliation of third party data streams and serious adverse event reconciliation with the safety database.
• Perform User Acceptance Testing (UAT) of clinical databases.
• Perform Quality Control (QC) of clinical databases.
• Perform ongoing updates of Data Management-related documentation, as needed.

Skills

Data management

EDC experience

UAT testing

QC

Education

Bachelor's degree or allied health certification

Tools

InformTM EDC

Job description

Kaztronix is seeking a Sr. Clinical Data Coordinator to support Phase I-III trials in accordance with ICH/GCP. The role emphasizes data review, UAT of clinical databases, QC activities, and maintaining Data Management documentation to ensure quality deliverables and timelines.

The candidate should have a bachelor’s degree or allied health certification, at least 3 years of data management experience, and experience with EDC systems. Oncology or inflammatory disease experience is preferred.