Contractor: Clinical Trial Operations Specialist

PTC Therapeutics, Inc; Maryland; On-site; USD 48,000 - 80,000; Full time

Job summary

PTC Therapeutics, Inc is seeking a Contractor, Clinical Trial Associate to support the Clinical Operations Excellence function across Standards, Inspection Preparedness and Readiness (IPR), Systems, and Vendor Alliance. The role provides day-to-day operational and administrative support for COE teams, helping ensure compliant processes and inspection-ready documentation.

You will collaborate with SMEs, manage documents, track deliverables, and assist with CAPA and quality checks in a fast-paced

Qualifications

• Bachelor's degree and 5+ years of clinical operations experience.
• Knowledge of ICH-GCP, trial documentation, and inspection readiness.
• Ability to manage multiple projects with strong organization.

Responsibilities

• Coordinate COE initiatives, deliverables and timelines.
• Manage COE repositories and meeting logistics.
• Support creation and upkeep of SOPs, templates, and guidance.
• Track CAPA and issue logs; maintain minutes and status updates.
• Assist with IP R/TMF activities and readiness activities.

Skills

Regulatory knowledge

Planning and time management

Attention to detail

Data quality checks

Microsoft Office

CTMS/eTMF familiarity

Communication

Independent & collaborative work

Problem solving

Process improvement

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 Clinical Operations Excellence function across Standards, Inspection Preparedness and Readiness (IPR), Systems, and Vendor Alliance. The role provides day-to-day operational and administrative support for COE teams, helping ensure compliant processes and inspection-ready documentation.

You will collaborate with SMEs, manage documents, track deliverables, and assist with CAPA and quality checks in a fast-paced