Clinical Operations & COE Coordinator

PTC Therapeutics, Inc; Warren Township (NJ); On-site; USD 48,000 - 80,000; Full time

Job summary

PTC Therapeutics, Inc. is seeking a Contractor, Clinical Trial Associate (CTA) to support the COE within Clinical Operations.

The role provides daily operational and administrative support across standards, inspection readiness, systems, and vendor alliances to ensure compliant processes and documentation. You will maintain controlled documents, coordinate meetings, and assist with SOP development, CAPA tracking, and readiness activities.

Qualifications

• Requires 5+ years in clinical operations in biotech/pharma
• Knowledge of ICH-GCP and inspection readiness concepts
• Proficiency with MS Office and clinical systems
• Strong planning, organization and time management
• Excellent written and verbal communication

Responsibilities

• Coordinate COE initiatives, deliverables and timelines
• Maintain COE repositories (SharePoint/Teams) and ensure content is current
• Support creation and upkeep of SOPs, templates, and guidance documents
• Assist with CAPA and issue tracking, including meeting minutes
• Coordinate inspection readiness activities and readiness checklists
• Provide admin support for clinical systems and change management

Skills

Analytical thinking

Communication

Time management

Independent & collaborative work

Problem solving

Education

Bachelor's degree in a relevant discipline

Tools

CTMS

eTMF

Microsoft Office

LMS

Job description

PTC Therapeutics, Inc. is seeking a Contractor, Clinical Trial Associate (CTA) to support the COE within Clinical Operations.

The role provides daily operational and administrative support across standards, inspection readiness, systems, and vendor alliances to ensure compliant processes and documentation. You will maintain controlled documents, coordinate meetings, and assist with SOP development, CAPA tracking, and readiness activities.