Lead Clinical Operations Manager - Trials & Strategy

PTC Therapeutics, Inc; Connecticut; Hybrid; USD 137,000 - 172,000; Full time

Benefits offered by this job

Short- & long-term incentives

Medical, dental, vision benefits

Retirement savings plans

Hybrid work arrangement

Job summary

PTC Therapeutics, Inc is seeking a Senior Manager, Clinical Operations to oversee planning, execution, and oversight of clinical trials across development programs. You will ensure compliance with ICH-GCP, SOPs, and study protocols, and collaborate with internal and external stakeholders to deliver trials on time and within budget.

You may have direct reports and will mentor junior staff while driving quality and efficiency in global trial delivery. Travel is approximately 20%.

Qualifications

• Bachelor's degree in a scientific discipline and 7+ years of global clinical research experience.
• Strong knowledge of ICH-GCP guidelines and global clinical trial regulations.
• Proven leadership and ability to manage and mentor staff.
• Excellent project management and organizational skills.

Responsibilities

• Lead or support the operational execution of Phase I-IV clinical trials.
• Serve as Lead Clinical Trial Manager for assigned studies and manage timelines and budgets.
• Develop study plans, timelines, and milestone tracking.
• Oversee vendor oversight and performance of service providers.
• Collaborate with cross-functional teams to align on strategy and timelines.
• Ensure compliance with ICH-GCP and global regulatory requirements.
• Lead site identification, activation, and monitoring oversight.
• Provide leadership and mentorship to junior staff.

Skills

ICH-GCP knowledge

Clinical trial operations

Cross-functional leadership

Project management

Vendor oversight

Budget management

Communication skills

Problem solving

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 oversee planning, execution, and oversight of clinical trials across development programs. You will ensure compliance with ICH-GCP, SOPs, and study protocols, and collaborate with internal and external stakeholders to deliver trials on time and within budget.

You may have direct reports and will mentor junior staff while driving quality and efficiency in global trial delivery. Travel is approximately 20%.