Contract Clinical Trial Ops Lead (CTA)

PTC Therapeutics, Inc; New York (NY); 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 (COE) function within the Clinical Operations department.

This role provides day-to-day operational and administrative support to COE teams across Standards, Inspection Preparedness and Readiness (IPR), Systems, and Vendor Alliance, helping ensure consistent processes, inspection-ready documentation practices, and effective use of clinical operations technologies.

Qualifications

• Bachelor's degree and 5+ years in clinical operations within biotech/pharma.
• Knowledge of ICH-GCP and inspection readiness concepts.
• Ability to manage multiple projects and meet deadlines.
• Proficient in Microsoft Office and clinical systems.
• Strong written and verbal communication skills.
• Ability to work independently and in a matrixed team.
• Excellent analytical and problem-solving abilities.
• Continuous improvement mindset with proactive mindset.

Responsibilities

• Coordinate COE initiatives, deliverables and timelines.
• Schedule working group meetings; agendas, minutes, action items.
• Maintain COE repositories (SharePoint/Teams) and ensure content is organized.
• Create and update best practices, job aids, FAQs, onboarding materials.
• Assist with SOPs, templates, tools and guidance documents.
• Manage controlled documents and records (version control, distribution).
• Support IP/IR/TMF activities with checks and reconciliation.
• Coordinate inspection readiness activities and mock inspections.
• Assist CAPA and issue tracking with logs and minutes.

Skills

ICH-GCP knowledge

MS Office proficient

CTMS/eTMF experience

Data quality checks

Meeting minutes / status summaries

Project coordination

Communication skills

Independent & team collaboration

Time management

Education

Bachelor's degree in a relevant discipline

Tools

SharePoint/Teams

CTMS

eTMF

Job description

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

This role provides day-to-day operational and administrative support to COE teams across Standards, Inspection Preparedness and Readiness (IPR), Systems, and Vendor Alliance, helping ensure consistent processes, inspection-ready documentation practices, and effective use of clinical operations technologies.