Clinical Trial Operations Specialist

ProPharma Group; Raleigh, Northern (NC, KY); Hybrid; USD 60,000 - 110,000; Full time

Job summary

ProPharma Group in the United States is seeking a Clinical Project Specialist to provide administrative and project management support for assigned clinical studies and projects. You will work closely with study teams to ensure efficient, compliant, and timely study execution.

Key duties include document development, reconciliation, tracking across CTMS/EDC and related systems, meeting coordination, and proactive risk escalation.

Qualifications

• Bachelor’s degree preferred; comparable training considered.
• 2+ years in pharmaceutical/biotech/CRO clinical research preferred.
• Experience supporting multiple clinical studies and study teams preferred.

Responsibilities

• Performs administrative and project support related to clinical trial execution.
• Supports day-to-day operations in compliance with SOPs, ICH/GCP, and study requirements.
• Assists with document collection, tracking, filing, and reconciliation.
• Develops and distributes site binders and study materials as requested.
• Tracks and maintains study information using trackers and databases.
• Sets up meetings, prepares agendas, takes minutes, and distributes materials.
• Escalates issues or risks impacting deliverables; communicates with stakeholders.
• Supports study systems like CTMS, eTMF, EDC, IVRS/IWRS, and other platforms.

Skills

Project management

Communication

MS Office

CTMS experience

Organizational skills

Cross-functional collaboration

Education

Bachelor's degree preferred

Tools

CTMS

EDC

IVRS/IWRS

Microsoft Excel

Job description

ProPharma Group in the United States is seeking a Clinical Project Specialist to provide administrative and project management support for assigned clinical studies and projects. You will work closely with study teams to ensure efficient, compliant, and timely study execution.

Key duties include document development, reconciliation, tracking across CTMS/EDC and related systems, meeting coordination, and proactive risk escalation.