Clinical Operations Leader — Senior Manager, Trials

PTC Therapeutics, Inc; Pennsylvania; On-site; USD 137,000 - 172,000; Full time

Job summary

PTC Therapeutics, Inc. is seeking a Senior Manager, Clinical Operations to lead the operational planning, execution, and oversight of global clinical trials across programs. This role may serve as Lead Clinical Trial Manager or function as a key operational contributor within a program team.

You will ensure trials comply with ICH-GCP, SOPs, and study protocols, work with CROs and internal stakeholders, manage timelines, budgets, and quality, and mentor junior team members.

Qualifications

• Bachelor's degree in a scientific field and 7+ years in clinical research or related environment.
• Strong knowledge of ICH-GCP guidelines and global trial regulations.
• Ability to lead clinical trial operations and cross‑functional teams.
• Experience leading, coaching, and mentoring direct reports if applicable.
• Excellent project management, organizational, and communication skills.
• Experience with risk-based quality management and vendor oversight.
• Ability to balance strategic oversight with hands-on execution.

Responsibilities

• Lead or support the operational execution of Phase I‑IV clinical trials.
• Serve as Lead Clinical Trial Manager for assigned studies with timelines and milestones.
• Develop and manage study documents: CTMPs, timelines, budgets.
• Oversee start‑up, conduct, and close‑out activities.
• Provide operational oversight of CROs and service providers.
• Monitor performance metrics to ensure quality and timelines.
• Collaborate with Clinical Development, Data Management, Regulatory Affairs, and QA.
• Ensure compliance with ICH‑GCP and global regulations; support inspections.

Skills

Leadership

Project management

Communication

Risk management

Cross-functional collaboration

Education

Bachelor's degree in a scientific discipline

Tools

Microsoft Office Suite

Job description

PTC Therapeutics, Inc. is seeking a Senior Manager, Clinical Operations to lead the operational planning, execution, and oversight of global clinical trials across programs. This role may serve as Lead Clinical Trial Manager or function as a key operational contributor within a program team.

You will ensure trials comply with ICH-GCP, SOPs, and study protocols, work with CROs and internal stakeholders, manage timelines, budgets, and quality, and mentor junior team members.