Clinical Operations Lead - Trials & Strategy

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

Job summary

PTC Therapeutics, Inc. in Delaware is seeking a Senior Manager, Clinical Operations to oversee the planning, execution, and oversight of clinical trials across development programs.

You will lead or serve as Lead Clinical Trial Manager, ensuring trials meet regulatory requirements, ICH-GCP guidelines, SOPs, and study protocol while coordinating with internal teams and external partners. The role requires strong leadership, cross-functional collaboration, risk management, vendor oversight, and

Qualifications

• Bachelor’s degree in a scientific discipline and 7 years of US and/or global experience in clinical research in a pharmaceutical, biotechnology, CRO or related environment.
• Strong knowledge of ICH-GCP guidelines and global clinical trial regulations.
• Demonstrated ability to lead clinical trial operations and cross-functional teams.
• Demonstrated leadership ability and experience managing, coaching and mentoring direct reports (if managing people).
• Strong project management and organizational skills.
• Experience with risk-based quality management and vendor oversight models.
• Analytical thinker with excellent communication, collaboration, and problem-solving abilities.

Responsibilities

• Lead or support the operational execution of Phase I-IV clinical trials, depending on study complexity and program needs.
• Serve as Lead Clinical Trial Manager for assigned studies, with responsibility for study timelines, operational strategy, and study deliverables.
• Develop and manage key study documents, including Clinical Trial Management Plans, study timelines and milestone tracking, vendor scopes of work and operational budgets.
• Oversee study start-up, conduct, and close-out activities.
• Provide operational oversight of Clinical CROs and other service providers to ensure delivery of services.
• Monitor service provider performance, study metrics, and key performance indicators to ensure study quality and timelines.

Skills

ICH-GCP knowledge

Leadership

Project management

Cross-functional collaboration

Vendor oversight

Regulatory compliance

Communication skills

Education

Bachelor’s degree in a scientific discipline

Tools

Microsoft Office Suite

Job description

PTC Therapeutics, Inc. in Delaware is seeking a Senior Manager, Clinical Operations to oversee the planning, execution, and oversight of clinical trials across development programs.

You will lead or serve as Lead Clinical Trial Manager, ensuring trials meet regulatory requirements, ICH-GCP guidelines, SOPs, and study protocol while coordinating with internal teams and external partners. The role requires strong leadership, cross-functional collaboration, risk management, vendor oversight, and