Clinical Trials Project Specialist - Study Ops & Tracking

PPG US ProPharma Group, LLC; Raleigh (NC); On-site; USD 60,000 - 86,000; Full time

Job summary

ProPharma is seeking a Clinical Project Specialist to provide administrative and project management support for assigned clinical studies, coordinating with study teams to ensure compliant and timely execution. The role involves document development, tracking, site materials, and study trackers using CTMS, eTMF, and other systems, with strong emphasis on communication and organization.

Candidates should have a bachelor’s degree and 2+ years in pharma/biotech CRO settings, with experience in

Qualifications

• Bachelor’s degree preferred; candidates without a formal degree may be considered with relevant training/experience.
• 2+ years of pharmaceutical/biotech/CRO/clinical research experience preferred.
• Experience supporting multiple clinical studies, project teams, or study-related systems is preferred.

Responsibilities

• Provide administrative and project support for clinical studies in compliance with SOPs and ICH/GCP guidelines.
• Assist with development, formatting, review, and reconciliation of study documents.
• Track and maintain study information using CTMS, eTMF, EDC, and other trackers; prepare agendas and meeting minutes.
• Coordinate with study teams, sites, and stakeholders to ensure timely study execution and issue escalation.
• Support study material development and protocol-related documentation; assist with site binders and study materials.

Skills

Verbal & written communication

Organizational skills

Attention to detail

Project management

Multitasking

Education

Bachelor's degree

Relevant training/experience

Tools

CTMS

eTMF

EDC

IVRS/IWRS

Microsoft Office

Job description

ProPharma is seeking a Clinical Project Specialist to provide administrative and project management support for assigned clinical studies, coordinating with study teams to ensure compliant and timely execution. The role involves document development, tracking, site materials, and study trackers using CTMS, eTMF, and other systems, with strong emphasis on communication and organization.

Candidates should have a bachelor’s degree and 2+ years in pharma/biotech CRO settings, with experience in