Clinical Trial Operations Coordinator

PTC Therapeutics, Inc; Bridgeport (CT); On-site; USD 48,000 - 80,000; Full time

Job summary

PTC Therapeutics, Inc. is seeking a Contractor, Clinical Trial Associate to support the COE within Clinical Operations. You will coordinate initiatives, maintain documents, and assist with ICH-GCP compliance and SOP adherence across systems.

Responsibilities include coordinating meetings, updating repositories, supporting TMF/IPR activities, and ensuring inspection readiness while communicating clearly with internal and external stakeholders in a fast-paced biotech environment.

Qualifications

• Bachelor's degree in a relevant discipline; 5+ years of clinical operations experience.
• Working knowledge of ICH-GCP, clinical trial documentation practices, and inspection readiness.
• Excellent planning, organization and time management skills.
• Proficiency in Microsoft Office and familiarity with clinical systems (CTMS, eTMF, eLearning/LMS).
• Effective written and verbal communication; able to draft clear meeting minutes, status summaries, and user communications.

Responsibilities

• Coordinate and track COE initiatives, deliverables, and timelines.
• Coordinate working group logistics (meetings, agendas, minutes, action items).
• Maintain COE-controlled repositories (SharePoint/Teams) to ensure content is organized, searchable, and current.
• Assist with development, formatting, publishing, and periodic review of COE standards, templates, tools, and guidance documents.
• Support IP/TMF IPR activities with eTMF and reconcile under direction of SMEs.
• Support inspection-readiness activities, including tracking deliverables and readiness checklists.

Skills

ICH-GCP knowledge

Planning & organization

Attention to detail

MS Office proficiency

Communication skills

Independent & collaborative work

Analytical thinking

Education

Bachelor's degree in a relevant discipline

Tools

CTMS

eTMF

eLearning/LMS

Microsoft Office

Job description

PTC Therapeutics, Inc. is seeking a Contractor, Clinical Trial Associate to support the COE within Clinical Operations. You will coordinate initiatives, maintain documents, and assist with ICH-GCP compliance and SOP adherence across systems.

Responsibilities include coordinating meetings, updating repositories, supporting TMF/IPR activities, and ensuring inspection readiness while communicating clearly with internal and external stakeholders in a fast-paced biotech environment.