Clinical Operations Coordinator — Trial Readiness

PTC Therapeutics, Inc; Philadelphia (Philadelphia County); On-site; USD 48,000 - 80,000; Part time

Job summary

PTC Therapeutics, Inc. is seeking a Contractor, Clinical Trial Associate (CTA) to support the Clinical Operations Excellence function. You will help manage COE initiatives, ensure inspection readiness, and maintain controlled documents across IP, TMF, and systems.

You will collaborate with SMEs to perform quality checks, coordinate meetings, and support SOPs, templates, and guidance documents while adhering to ICH-GCP and data integrity standards. Travel 20-30% is expected.

Qualifications

• Bachelor's degree in a relevant discipline and 5+ years in clinical operations/clinical trial operations.
• Working knowledge of ICH-GCP, clinical trial documentation, and inspection readiness concepts.
• Strong planning, organization and time management skills with the ability to manage multiple projects.
• Attention to detail and comfort with metrics, dashboards, and data quality checks.
• Proficiency in MS Office and familiarity with CTMS/eTMF/eLearning/LMS.
• Excellent written and verbal communication; able to draft meeting minutes and status summaries.
• Ability to work independently and collaboratively in a fast-paced, matrixed environment.
• Analytical thinker with problem-solving skills and a continuous improvement mindset.

Responsibilities

• Coordinate and track COE initiatives, deliverables, and timelines.
• Coordinate working group logistics, agendas, minutes, and action items.
• Maintain COE repositories ( COE mailbox, SharePoint/Teams ) and keep content current.
• Assist with development, formatting, publishing, and review of SOPs, templates, tools.
• Manage controlled documents and records with version control and archiving support.
• Support IP R/TMF IPR activities with eTMF including quality and completeness checks.
• Support inspection-readiness activities, tracking deliverables and readiness checklists.
• Coordinate mock inspections and follow-up documentation; ensure consistent filing conventions.

Skills

ICH-GCP

Time management

Data quality checks

MS Office

CTMS/eTMF

Communication

Independent & collaborative

Analytical thinking

Continuous improvement

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 function. You will help manage COE initiatives, ensure inspection readiness, and maintain controlled documents across IP, TMF, and systems.

You will collaborate with SMEs to perform quality checks, coordinate meetings, and support SOPs, templates, and guidance documents while adhering to ICH-GCP and data integrity standards. Travel 20-30% is expected.