Contractor, Clinical Trial Associate - Clinical Operations Excellence

PTC Therapeutics • Warren, DC

8d

About The Position

The Contractor, Clinical Trial Associate (CTA) supports the Clinical Operations Excellence (COE) function within the Clinical Operations department. The role provides day-to-day operational and administrative support to teams working across Standards, Inspection Preparedness and Readiness (IPR), Systems, and Vendor Alliance. It helps promote consistent processes, inspection-ready documentation practices, and effective use of clinical operations technologies, while supporting adherence to applicable regulatory requirements and company SOPs.

The CTA coordinates COE initiatives, deliverables, timelines, and working-group logistics; maintains COE repositories; and helps create and maintain best practices, job aids, FAQs, onboarding materials, standards, templates, tools, and guidance documents. The role also supports controlled-document and record management, IPR and eTMF quality and completeness checks, inspection-readiness activities, CAPA and issue tracking, and administrative support for clinical systems. The position requires effective collaboration with department stakeholders and compliance with applicable SOPs, GCP, internal standards, and data-integrity expectations. Travel is expected at 20–30%.

Requirements

• Bachelor’s degree in a relevant discipline.
• At least 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.
• Strong 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, including Excel, PowerPoint, and Word.
• Effective written and verbal communication skills, including the ability to draft clear meeting minutes, status summaries, and user communications.
• Ability to work independently and collaboratively in a fast-paced, matrixed environment with internal and external team members.
• Analytical thinking and problem-solving skills, with the ability to adapt to changing priorities and deadlines.
• Continuous-improvement mindset, including the ability to identify gaps, propose practical enhancements, and follow through.
• Willingness to travel 20–30%.

Responsibilities

• Coordinate and track general COE initiatives, deliverables, and timelines.
• Coordinate working-group logistics, including meeting scheduling, agendas, minutes, and action-item tracking.
• Maintain COE-controlled repositories, such as the COE mailbox and SharePoint/Teams sites, ensuring content is organized, searchable, and current.
• Support creation and upkeep of best practices, job aids, FAQs, and onboarding materials for Clinical Operations staff.
• Assist with development, formatting, publishing, and periodic review of Clinical Operations standards, templates, tools, and guidance documents.
• Manage COE-related controlled documents and records, including version control, distribution lists, and archive or retention support.
• Support IPR/TMF IPR activities with eTMF, including periodic quality checks, completeness checks, and reconciliation support under SME direction.
• Support inspection-readiness activities by tracking deliverables, maintaining readiness checklists, and monitoring action items.
• Coordinate mock-inspection or readiness-meeting logistics and support follow-up documentation.
• Help maintain centralized inspection-readiness resources and consistent filing and naming conventions.
• Support CAPA and issue tracking by maintaining logs, status updates, and meeting minutes as directed.
• Provide administrative support for Clinical Operations systems, including user-access request coordination, training coordination, and basic user-support triage.
• Support system-related change management, including drafting communications, coordinating training-session logistics, and tracking attendance.
• Perform work in compliance with applicable SOPs, GCP, internal standards, and data-integrity expectations.
• Interface with department stakeholders to support COE initiatives.

What This Job Offers

• Career Level: Mid Level