Senior Clinical Operations Lead

PTC Therapeutics, Inc.

New Jersey

On-site

USD 137,000 - 172,000

Full time

32 hours ago
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Benefits offered by this job

Short- and long-term incentives
Medical, dental, vision plans
Retirement savings plans

Job summary

PTC Therapeutics, Inc. seeks a Senior Manager, Clinical Operations to plan, execute, and oversee global clinical trials across Phase I–IV, ensuring compliance with ICH-GCP, SOPs, and budgets.

You will lead study timelines, manage CROs and vendors, mentor junior staff, and partner with Clinical Development, Data Management, Regulatory, and Quality Assurance to deliver high-quality data on time. Travel about 20% is expected; base salary range is disclosed; strong leadership and risk management

Qualifications

  • Bachelor’s degree in a scientific discipline with 7+ years in clinical research.
  • Strong knowledge of ICH-GCP guidelines and global trial regulations.
  • Experience leading clinical trial operations and cross-functional teams.
  • Experience with risk-based quality management and vendor oversight.
  • Ability to balance strategic oversight with operational execution.
  • Experience with rare disease clinical trials.

Responsibilities

  • Lead or support Phase I-IV trials with timelines and budgets.
  • Serve as Lead Clinical Trial Manager for assigned studies.
  • Develop study documents and budgets; oversee start-up and close-out.
  • Oversee CROs and service providers; monitor performance and KPIs.
  • Collaborate across Clinical Development, Regulatory, Data Management, and QA.

Skills

Clinical operations leadership
Project management
Cross-functional collaboration
Mentorship
Regulatory compliance

Education

Bachelor’s degree in a scientific discipline

Tools

Microsoft Office Suite
Regulatory systems knowledge

Job description

PTC Therapeutics, Inc. seeks a Senior Manager, Clinical Operations to plan, execute, and oversee global clinical trials across Phase I–IV, ensuring compliance with ICH-GCP, SOPs, and budgets.

You will lead study timelines, manage CROs and vendors, mentor junior staff, and partner with Clinical Development, Data Management, Regulatory, and Quality Assurance to deliver high-quality data on time. Travel about 20% is expected; base salary range is disclosed; strong leadership and risk management

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