Sr. Clinical Data Coordinator

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

Job Summary

The Sr. Clinical Data Coordinator performs activities pertaining to the conduct of Phase I-IlI clinical trials in accordance with ICH/Good Clinical Practices (GCP) and other relevant procedures and guidelines to ensure that a quality work product is produced and timelines and deliverables are met.

Summary of the Essential Functions of the Job

• 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.

Minimum Requirements

• Bachelor's degree OR certification in a related allied health profession from an appropriately accredited institution (i.e. RN, MT, PA, RT) is preferred, but individuals with commensurate experience will be considered.
• Minimum of 3 years of data management experience is required.
• Experience with Electronic Data Capture (EDC) system(s) is required.
• Experience with Oracle Inc.'s InformTM EDC system is preferred.
• Oncology and/or inflammatory therapeutic area experience is preferred.

Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.

By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.