Senior Manager, Clinical Operations

PTC Therapeutics seeks a Senior Manager of Clinical Operations to oversee the planning, execution, and compliance of clinical trials across Phase I-IV studies. The role involves managing operational strategy, cross-functional collaboration, vendor oversight, and may include direct report management in support of the company's rare disease therapeutic programs.

Responsibilities

• Lead or support operational execution of Phase I-IV clinical trials as assigned Lead Clinical Trial Manager
• Develop and manage clinical trial management plans, timelines, budgets, and vendor scope of work documents
• Provide operational oversight of CROs and service providers to ensure contract compliance and performance standards
• Ensure clinical trials comply with ICH-GCP guidelines, regulatory requirements, and company SOPs
• Manage direct reports with mentorship, guidance, and performance oversight of junior clinical operations staff

Requirements

• Bachelor's degree in scientific discipline with 7+ years clinical research experience
• Strong knowledge of ICH-GCP guidelines and global clinical trial regulations
• Demonstrated ability to lead clinical trial operations and cross-functional teams
• Experience with risk-based quality management and vendor oversight
• Project management and organizational skills with analytical mindset
• Leadership experience managing, coaching, and mentoring direct reports
• Proficiency with Microsoft Office Suite