Clinical Trial Associate: Operations & Inspection Readiness

PTC Therapeutics, Inc; Massachusetts; 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 Clinical Operations Excellence function across COE standards, IPR, systems, and Vendor Alliance.

The role provides day-to-day operational and administrative support to ensure inspection-ready documentation and compliant trial processes. Candidates should have a Bachelor's degree and 5+ years in clinical operations within biotech/pharma.

Qualifications

• Bachelor's degree in a relevant discipline with 5+ years of clinical operations experience.
• Solid knowledge of ICH-GCP, trial documentation, and inspection readiness.
• Demonstrated ability to plan, organize, and manage multiple projects.
• Strong attention to detail and data quality mindset.

Responsibilities

• Coordinate COE initiatives, deliverables, and timelines.
• Manage COE repos and documentation tracking (SharePoint/Teams).
• Develop and maintain best practices, job aids, and onboarding materials.
• Support SOPs, templates, and tools for Clinical Operations.
• Assist with CAPA and issue tracking; document meeting minutes.
• Support IPR/TMF activities and readiness for inspections.
• Coordinate mock inspections and readiness meetings.

Skills

ICH-GCP knowledge

Project planning

Attention to detail

MS Office

Communication

Independent working

Team collaboration

Analytical thinking

Process improvement

Education

Bachelor's degree in a relevant discipline

Tools

CTMS

eTMF

LMS

Job description

PTC Therapeutics, Inc. is seeking a Contractor, Clinical Trial Associate (CTA) to support the Clinical Operations Excellence function across COE standards, IPR, systems, and Vendor Alliance.

The role provides day-to-day operational and administrative support to ensure inspection-ready documentation and compliant trial processes. Candidates should have a Bachelor's degree and 5+ years in clinical operations within biotech/pharma.