Contractor Clinical Trial Operations Specialist

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

Job summary

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

You will provide day-to-day operational and administrative support to ensure compliant processes and inspection-ready documentation. You will help maintain COE repositories, assist with best practices, templates, and onboarding materials, and manage documentation with version control, while coordinating inspections

Qualifications

• Bachelor’s degree in a relevant discipline and a minimum of 5+ years of clinical operations and/or clinical trial operations experience within the biotechnology or pharmaceutical industry.
• Working knowledge of ICH-GCP, clinical trial documentation practices, and inspection readiness concepts.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
• High attention to detail and comfort working with metrics, dashboards, and data quality checks.
• Proficiency in Microsoft Office (Excel, PowerPoint, Word) and familiarity with clinical systems (e.g., CTMS, eTMF, eLearning/LMS).
• Effective written and verbal communication; able to draft clear meeting minutes, status summaries, and user communications.
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Continuous improvement mindset; able to identify gaps, propose practical enhancements, and follow through.

Responsibilities

• Coordinate and track COE initiatives, deliverables, and timelines.
• Coordinate working group logistics (scheduling, agendas, minutes, action items).
• Maintain COE repositories to ensure content is organized, searchable, and current.
• Assist with development and upkeep of best practices, job aids, FAQs, and onboarding materials.
• Support development, formatting, publishing, and review of Clinical Operations standards and tools.
• Manage controlled documents and records with version control and distribution lists.
• Support IP/TMF activities with eTMF, including quality checks and reconciliation.
• Support inspection-readiness activities and readiness checklists.
• Coordinate mock inspections and readiness meeting logistics and follow-up docs.
• Maintain centralized inspection-readiness resources and filing conventions.
• Support CAPA and issue tracking with logs and minutes.

Skills

ICH-GCP knowledge

Clinical operations

Documentation practices

Microsoft Office

Communication

Time management

Team collaboration

Problem solving

Education

Bachelor’s degree in a relevant discipline

Tools

CTMS

eTMF

LMS

SharePoint/Teams

Job description

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

You will provide day-to-day operational and administrative support to ensure compliant processes and inspection-ready documentation. You will help maintain COE repositories, assist with best practices, templates, and onboarding materials, and manage documentation with version control, while coordinating inspections