Clinical Trial Operations Coordinator

PTC Therapeutics; New Jersey; 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 (COE). You will help ensure SOP compliance, inspection readiness, and effective use of systems like CTMS and eTMF.

You will coordinate COE initiatives, manage documents, and support CAPA and issue tracking while operating within a fast-paced, matrixed team. Travel will be required 20–30%, with an hourly pay range disclosed by the company.

Qualifications

• Bachelor's degree in a relevant discipline and a minimum of 5+ years of clinical operations and/or clinical trial operations experience in biotech/pharma.
• 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 with metrics, dashboards, and data quality checks.
• Proficiency in Microsoft Office (Excel, PowerPoint, Word) and familiarity with clinical systems (CTMS, eTMF, eLearning/LMS).
• Ability to draft clear meeting minutes, status summaries, and user communications.
• Ability to work both independently and in a matrixed team environment.
• Analytical thinker with problem-solving skills and adaptability to changing priorities.

Responsibilities

• Coordinate and track COE initiatives, deliverables, and timelines.
• Coordinate working group logistics: scheduling, agendas, minutes, action item tracking.
• Maintain COE repositories (SharePoint/Teams) to keep content organized and current.
• Support development and upkeep of best practices, job aids, FAQs, and onboarding materials.
• Assist with production of standards, templates, tools, and guidance documents.
• Manage controlled documents and records (version control, distribution lists).
• Support IPR/TMF activities with eTMF, including quality checks and reconciliations.
• Support inspection-readiness activities and maintain readiness checklists.
• Coordinate mock inspections and readiness meetings, and document follow-ups.
• Maintain centralized inspection-readiness resources and filing naming conventions.
• Support CAPA and issue tracking with logs and meeting minutes.

Skills

Time management

Analytical thinking

Planning

Attention to detail

Education

Bachelor's degree in a relevant discipline

Tools

CTMS

eTMF

eLearning/LMS

Job description

PTC Therapeutics is seeking a Contractor, Clinical Trial Associate (CTA) to support the Clinical Operations Excellence (COE). You will help ensure SOP compliance, inspection readiness, and effective use of systems like CTMS and eTMF.

You will coordinate COE initiatives, manage documents, and support CAPA and issue tracking while operating within a fast-paced, matrixed team. Travel will be required 20–30%, with an hourly pay range disclosed by the company.