Clinical Trial Operations Specialist, COE & Readiness

PTC Therapeutics, Inc; Washington (District of Columbia); On-site; USD 48,000 - 80,000; Full time

Job summary

PTC Therapeutics is seeking a Contractor, Clinical Trial Associate (CTA) to support the Clinical Operations Excellence function. You will provide day-to-day operational and administrative support across Standards, Inspection Preparedness and Readiness, Systems, and Vendor Alliance to ensure inspection-ready documentation and compliant processes.

The role requires a Bachelor's degree and 5+ years in clinical operations, proficiency in CTMS/eTMF, strong communication, and the ability to work in a

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.

Responsibilities

• Coordinate COE initiatives, deliverables, and timelines.
• Coordinate working group logistics, agendas, minutes, and action item tracking.
• Maintain COE repositories (COE mailbox, SharePoint/Teams) for organized, searchable content.
• Support creation and upkeep of best practices, job aids, FAQs, and onboarding materials.
• Assist with development, formatting, publishing, and review of COE standards and guidance documents.
• Manage controlled documents and records (version control, distribution lists, archive/retention).
• Support IPR/TMF activities with eTMF, including quality checks and reconciliations.
• Assist inspection-readiness activities and readiness documentation.

Skills

Clinical operations

SOP adherence

Documentation

Meeting minutes

MS Office

Data quality

Analytical thinking

Communication skills

Education

Bachelor's degree

Tools

CTMS

eTMF

SharePoint

LMS

Job description

PTC Therapeutics is seeking a Contractor, Clinical Trial Associate (CTA) to support the Clinical Operations Excellence function. You will provide day-to-day operational and administrative support across Standards, Inspection Preparedness and Readiness, Systems, and Vendor Alliance to ensure inspection-ready documentation and compliant processes.

The role requires a Bachelor's degree and 5+ years in clinical operations, proficiency in CTMS/eTMF, strong communication, and the ability to work in a