Clinical Trial Operations Specialist

PTC Therapeutics, Inc; Delaware; On-site; USD 48,000 - 80,000; Full time

Job summary

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

You will provide day-to-day operational and administrative support across Standards, IPR, Systems, and Vendor Alliance, helping ensure compliant processes and inspection-ready documentation. This role requires collaboration with SMEs, change management, and meticulous documentation, including COE repositories, CAPA tracking, and readiness activities.

Qualifications

• Bachelor's degree and 5+ years in clinical operations or clinical trial operations within biopharma.
• Working knowledge of ICH-GCP and inspection readiness concepts.
• Ability to draft clear meeting minutes, status summaries, and user communications.

Responsibilities

• Coordinate and track COE initiatives, deliverables, and timelines.
• Coordinate COE logistics for meetings and maintain minutes and action-item trackers.
• Maintain COE repositories (SharePoint/Teams) to ensure content is organized and current.
• Support development, formatting, publishing, and periodic review of SOPs, templates, tools, and guidance documents.

Skills

ICH-GCP knowledge

Clinical operations experience

Regulatory/compliance

Documentation and records management

Communication and collaboration

Attention to detail

Education

Bachelor's degree in a relevant discipline

Tools

CTMS

eTMF

Microsoft Office

SharePoint/Collaboration tools

Job description

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

You will provide day-to-day operational and administrative support across Standards, IPR, Systems, and Vendor Alliance, helping ensure compliant processes and inspection-ready documentation. This role requires collaboration with SMEs, change management, and meticulous documentation, including COE repositories, CAPA tracking, and readiness activities.