Senior Clinical Operations Leader

PTC Therapeutics, Inc.

Connecticut

On-site

USD 137,000 - 172,000

Full time

16 hours ago
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Benefits offered by this job

Short-term incentives
Long-term incentives
Medical insurance
Dental insurance
Vision insurance
Retirement savings plan

Job summary

PTC Therapeutics, Inc. is seeking a Senior Manager, Clinical Operations to oversee operational planning and execution of global clinical trials. This role ensures adherence to ICH-GCP, SOPs, timelines, and budgets while collaborating with internal teams and external service providers.

You will lead trial management activities, mentor staff, manage vendor relationships, and contribute to study planning, risk mitigation, and regulatory readiness across Phase I–IV programs.

Qualifications

  • Bachelor’s degree in a scientific discipline with 7+ years of clinical research experience.
  • Experience leading clinical operations in pharma/biotech/CRO settings.
  • Strong knowledge of ICH-GCP guidelines and global regulations.

Responsibilities

  • Lead or support execution of Phase I–IV trials with program teams.
  • Serve as Lead Clinical Trial Manager for assigned studies and timelines.
  • Develop study documents and budgets.
  • Oversee site activation, monitoring, data review, and issue resolution.
  • Provide mentorship and leadership for junior staff and cross-functional partners.
  • Ensure inspection readiness and adherence to SOPs and regulatory requirements.

Skills

Cross-functional leadership
Clinical trial operations
Project management
Risk management
Analytical thinking
Communication
Inspection readiness
Vendor oversight
Budget management
Team mentorship

Education

Bachelor’s degree in a scientific discipline

Tools

Microsoft Office

Job description

PTC Therapeutics, Inc. is seeking a Senior Manager, Clinical Operations to oversee operational planning and execution of global clinical trials. This role ensures adherence to ICH-GCP, SOPs, timelines, and budgets while collaborating with internal teams and external service providers.

You will lead trial management activities, mentor staff, manage vendor relationships, and contribute to study planning, risk mitigation, and regulatory readiness across Phase I–IV programs.

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