End-to-End Clinical Operations Contractor

PTC Therapeutics; New Jersey; On-site; USD 83,000 - 110,000; Full time

Job summary

PTC Therapeutics, a global biopharmaceutical company, seeks a Contractor, Clinical Operations in New Jersey to lead the execution of clinical trials from design through close-out in compliance with regulatory requirements. You will work cross-functionally with internal teams and external partners, prepare protocols and regulatory documents, manage timelines and budgets, and support submissions while ensuring data quality and adherence to GCP/GMP/ICH guidelines.

Travel 0-10% may be required.

Qualifications

• Bachelor’s degree in a scientific discipline; 7+ years clinical research experience.
• Experience in pharmaceutical/biotech/CRO environments.
• Strong knowledge of regulatory requirements and clinical trial processes.

Responsibilities

• Lead, direct and contribute to planning, execution, and reporting of clinical trials from design through close-out.
• Collaborate with internal/external teams on trial strategies and documents.
• Prepare study protocols, manuals, ICFs, and regulatory submissions.
• Manage investigational sites, budgets, and vendor contracts; coordinate investigator meetings.
• Monitor timelines and budgets; report progress at team/investigator meetings.
• Support regulatory submissions and data interpretation for study reports.
• Ensure data quality and compliance with GCP, GMP, and ICH guidelines.
• Address site/monitor inquiries and maintain trial conduct.

Skills

Clinical project management

GCP/GMP/ICH knowledge

Regulatory submissions

Cross-functional teamwork

Data review & reporting

Project budgeting

Microsoft Word

Microsoft Excel

Scientific writing

Time management

Education

Bachelor’s degree in a scientific discipline

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Microsoft Project

Job description

PTC Therapeutics, a global biopharmaceutical company, seeks a Contractor, Clinical Operations in New Jersey to lead the execution of clinical trials from design through close-out in compliance with regulatory requirements. You will work cross-functionally with internal teams and external partners, prepare protocols and regulatory documents, manage timelines and budgets, and support submissions while ensuring data quality and adherence to GCP/GMP/ICH guidelines.

Travel 0-10% may be required.