Lead Clinical Operations Manager, Trials & Compliance

PTC Therapeutics, Inc; Baltimore (MD); On-site; USD 137,000 - 172,000; Full time

Benefits offered by this job

Incentives (short- and long-term)

Health, dental, vision benefits

Retirement savings plans

Job summary

PTC Therapeutics, Inc. is seeking a Senior Manager, Clinical Operations to lead the execution and oversight of global clinical trials.

You will ensure regulatory compliance, adherence to ICH-GCP guidelines, and collaboration across internal and external partners to deliver trials on time and within budget. The role may involve leadership of direct reports and requires strong cross-functional coordination, risk management, and strategic oversight to advance therapies for patients with unmet

Qualifications

• Bachelor's degree in a scientific discipline required.
• 7+ years of progressively responsible US/global clinical research experience preferred.
• Strong knowledge of ICH-GCP guidelines and global trial regulations.

Responsibilities

• Lead or support Phase I–IV clinical trials with program teams.
• Serve as Lead Clinical Trial Manager for assigned studies; manage timelines & budgets.
• Oversee study start-up, conduct, close-out, and vendor oversight.
• Collaborate with Clinical Development, Data Management, Regulatory Affairs and QA.
• Ensure compliance with SOPs and regulatory requirements; contribute to inspection readiness.

Skills

Leadership

Cross-functional collaboration

Project management

Communication skills

Education

Bachelor's degree in a scientific discipline

Job description

PTC Therapeutics, Inc. is seeking a Senior Manager, Clinical Operations to lead the execution and oversight of global clinical trials.

You will ensure regulatory compliance, adherence to ICH-GCP guidelines, and collaboration across internal and external partners to deliver trials on time and within budget. The role may involve leadership of direct reports and requires strong cross-functional coordination, risk management, and strategic oversight to advance therapies for patients with unmet