Senior Manager, Trial Readiness & Compliance

Genmab; Princeton (NJ); On-site; USD 107,000 - 161,000; Full time

Benefits offered by this job

Pension

Health insurance and wellness benefits

Paid time off

Employee support programs

Job summary

Genmab is seeking a Senior Manager, Inspection Readiness to support Clinical Trial Operations by embedding clinical compliance into trials and with service providers. This role ensures high-quality inspection readiness in line with GCP and regulatory requirements.

It is an individual contributor position with no direct reports. The successful candidate will drive process improvements, guide study teams, and develop training and tools for ongoing inspection readiness.

Qualifications

• Master’s degree in Life Sciences, Pharmacy, Medicine or related field.
• 8+ years of experience in Clinical Operations, Clinical Quality, Inspection Readiness or Clinical Compliance.
• Strong understanding of ICH-GCP regulations and regulatory requirements.
• Excellent written and verbal communication skills.

Responsibilities

• Design tools and processes for trial inspection readiness.
• Provide GCP and clinical compliance support to study teams.
• Lead inspection readiness training/tools for Clinical Trial Operations and stakeholders.
• Collaborate with GCP QA and support inspection setup during sponsor/site inspections.
• Develop lessons learned from inspection readiness and outcomes.

Skills

Clinical Operations

ICH-GCP regulations

Project management

Stakeholder management

Communication skills

Mentoring

Education

MSc in Life Sciences/Pharmacy/Medicine

Job description

Genmab is seeking a Senior Manager, Inspection Readiness to support Clinical Trial Operations by embedding clinical compliance into trials and with service providers. This role ensures high-quality inspection readiness in line with GCP and regulatory requirements.

It is an individual contributor position with no direct reports. The successful candidate will drive process improvements, guide study teams, and develop training and tools for ongoing inspection readiness.