Senior Clinical Trial Operations Lead

PTC Therapeutics, Inc; New Jersey; On-site; USD 137,000 - 172,000; Full time

Benefits offered by this job

Short- and long-term incentives

Medical/dental/vision plans

Retirement savings plans

Job summary

PTC Therapeutics, Inc is seeking a Senior Manager, Clinical Operations to lead the operational planning, execution, and oversight of clinical trials across development programs. You will collaborate with internal functions and external partners to ensure quality, timelines, and budget adherence.

In this role, you may serve as Lead Clinical Trial Manager or act as a key operational contributor within a broader program team, providing mentorship and ensuring compliance with ICH-GCP and SOPs.

Qualifications

• Bachelor's degree in a scientific discipline with at least 7 years in US/global clinical research.
• Strong knowledge of ICH-GCP guidelines and global clinical trial regulations.
• Proven ability to lead clinical trial operations and manage cross-functional teams.
• Experience managing, coaching, and mentoring direct reports (if managing people).

Responsibilities

• Lead or support the operational execution of Phase I-IV clinical trials, depending on study complexity and program needs.
• Serve as Lead Clinical Trial Manager for assigned studies, with responsibility for study timelines, operational strategy, and study deliverables.
• Develop and manage key study documents including: Clinical Trial Management Plans, Study timelines and milestone tracking, Vendor scopes of work and operation budgets.
• Oversee study start-up, conduct, and close-out activities.

Skills

Clinical trial operations

Lead cross-functional teams

ICH-GCP knowledge

Project management

Vendor oversight

Risk management

Analytical thinking

Communication skills

MS Office

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 lead the operational planning, execution, and oversight of clinical trials across development programs. You will collaborate with internal functions and external partners to ensure quality, timelines, and budget adherence.

In this role, you may serve as Lead Clinical Trial Manager or act as a key operational contributor within a broader program team, providing mentorship and ensuring compliance with ICH-GCP and SOPs.