Clinical Trial Operations Coordinator: Inspection Readiness

PTC Therapeutics, Inc; Lynnfield (MA); On-site; USD 48,000 - 80,000; Full time

Job summary

PTC Therapeutics, Inc. in Massachusetts is seeking a Contractor, Clinical Trial Associate (CTA) to support the Clinical Operations Excellence function. You will assist with day-to-day COE activities, SOP adherence, and inspection readiness across IP.R and vendor alliances.

Your role involves maintaining files, coordinating meetings, and preparing materials to ensure compliant, audit-ready processes. Strong knowledge of ICH-GCP and MS Office is essential for success in a fast-paced biotech

Qualifications

• Bachelor's degree in a relevant discipline and 5+ years of clinical operations experience.
• Working knowledge of ICH-GCP, SOPs, and inspection readiness concepts.
• Excellent planning, organization and time management skills.
• High attention to detail with metrics, dashboards and data quality checks.
• Proficiency in Microsoft Office and familiarity with clinical systems.

Responsibilities

• Coordinate COE initiatives, deliverables, and timelines.
• Coordinate working group logistics for COE activities.
• Maintain COE repositories to ensure content is organized.
• Support development and upkeep of best practices, job aids and onboarding materials.
• Assist with SOPs, templates, tools, and guidance documents.
• Manage controlled documents and records for COE.
• Support IP.R/TMF IPR activities with eTMF under SMEs.
• Support inspection-readiness activities and tracking deliverables.
• Coordinate mock inspections and readiness meeting logistics.
• Maintain centralized inspection-readiness resources and naming conventions.
• Support CAPA and issue tracking with logs and minutes.

Skills

ICH-GCP knowledge

Documentation practices

Planning & organization

Communication

MS Office

Education

Bachelor's degree in a relevant discipline

Tools

CTMS

eTMF

LMS familiarity

SharePoint

Job description

PTC Therapeutics, Inc. in Massachusetts is seeking a Contractor, Clinical Trial Associate (CTA) to support the Clinical Operations Excellence function. You will assist with day-to-day COE activities, SOP adherence, and inspection readiness across IP.R and vendor alliances.

Your role involves maintaining files, coordinating meetings, and preparing materials to ensure compliant, audit-ready processes. Strong knowledge of ICH-GCP and MS Office is essential for success in a fast-paced biotech