Remote Clinical Data Manager: Trial Data & Quality Lead

PPG US ProPharma Group, LLC; Raleigh (NC); Hybrid; USD 80,000 - 120,000; Full time

Job summary

ProPharma Group is seeking a Clinical Data Manager to lead data management activities for Phase I-III trials in accordance with ICH/GCP. You will ensure data quality, time, and budget targets.

The role involves developing and reviewing CRFs, DMPs, and eCRF guidelines, supporting UAT/QC, and mentoring senior coordinators. Flexible hybrid working arrangements and a strong emphasis on regulatory compliance are featured.

Qualifications

• Minimum 5 years of data management experience.
• Bachelor's degree or allied health certification preferred.
• Experience with EDC systems required (Oracle Inform EDC preferred).
• Oncology or inflammatory therapeutic area experience preferred.
• Project management experience within Data Management preferred.

Responsibilities

• Serve as the primary data management representative on project teams and ensure effective communication.
• Review, develop, and write clinical trial documents and manuals (CRFs, DMPs, eCRFs).
• Participate in UAT and QC activities as needed.
• Collaborate with CDAs to ensure data flow charts and import guidelines are developed.
• Provide training on CDM topics to site staff or vendors.
• Perform data review and discrepancy resolution as needed.

Skills

Data management

EDC systems

Clinical research

Project management

Oncology experience

CRO experience

Education

Bachelor's degree or allied health certification

Tools

Oracle Inform EDC

Job description

ProPharma Group is seeking a Clinical Data Manager to lead data management activities for Phase I-III trials in accordance with ICH/GCP. You will ensure data quality, time, and budget targets.

The role involves developing and reviewing CRFs, DMPs, and eCRF guidelines, supporting UAT/QC, and mentoring senior coordinators. Flexible hybrid working arrangements and a strong emphasis on regulatory compliance are featured.