Clinical Trial Ops Specialist – COE & IPR

PTC Therapeutics, Inc; Pennsylvania; 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.

You will provide day-to-day operational and admin support across Standards, IPR, Systems, and Vendor Alliance to ensure compliant, inspection-ready documentation and effective use of clinical operations technologies. Responsibilities include coordinating COE initiatives, maintaining repositories, and assisting with SOPs, CAPA, and readiness activities.

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, trial documentation practices, and inspection readiness concepts.
• Excellent planning, organization and time management with ability to manage multiple projects.
• High attention to detail and comfort with metrics, dashboards, and data quality checks.
• Proficiency in Microsoft Office and familiarity with clinical systems (CTMS, eTMF, LMS).
• Effective written and verbal communication; able to draft clear meeting minutes and summaries.
• Ability to work independently and in a matrixed team in a fast-paced environment.
• Analytical thinker with problem-solving skills and adaptability to changing priorities.

Responsibilities

• Coordinate COE initiatives, deliverables, and timelines.
• Organize COE meetings, agendas, minutes, and action tracking.
• Maintain COE repositories and ensure content is searchable and current.
• Help develop and update SOPs, templates, and guidance documents.
• Support inspection readiness activities, including documentation and readiness checks.
• Assist CAPA and issue tracking with logs and meeting minutes.
• Interface with stakeholders to support COE initiatives.
• Provide admin support for clinical systems and change management activities.

Skills

ICH-GCP knowledge

Planning & time management

Attention to detail

MS Office proficiency

CTMS/eTMF familiarity

Documentation & reporting

Communication

Independent & collaborative work

Analytical thinking

Problem solving

Education

Bachelor's degree in a relevant discipline

Tools

CTMS

eTMF

eLearning/LMS

Excel

PowerPoint

Word

Job description

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

You will provide day-to-day operational and admin support across Standards, IPR, Systems, and Vendor Alliance to ensure compliant, inspection-ready documentation and effective use of clinical operations technologies. Responsibilities include coordinating COE initiatives, maintaining repositories, and assisting with SOPs, CAPA, and readiness activities.