Senior Manager, Clinical Operations

PTC Therapeutics seeks a Senior Manager, Clinical Operations to oversee the operational execution of Phase I-IV clinical trials and ensure regulatory compliance. This role manages study timelines, vendor oversight, and cross-functional collaboration while potentially supervising junior team members.

Responsibilities

• Lead or support operational execution of Phase I-IV clinical trials with responsibility for timelines, strategy, and deliverables
• Provide oversight of clinical CROs and service providers to ensure contract compliance and service quality
• Ensure clinical trials comply with ICH-GCP guidelines, regulatory requirements, company SOPs, and study protocols
• Manage site identification, selection, and activation; review monitoring reports and study metrics
• Develop and manage clinical trial management plans, study timelines, vendor scopes, and operational budgets

Requirements

• Bachelor's degree in scientific discipline plus 7+ years clinical research experience in pharma/biotech/CRO
• 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 models
• Project management and organizational skills with analytical and problem-solving abilities
• Microsoft Office Suite proficiency
• Experience managing, coaching, and mentoring direct reports (if applicable)