Global Head of Clinical Process & Standards

Galderma; Boston (MA); On-site; USD 200,000 - 265,000; Full time

Job summary

Galderma is seeking a Head of Clinical Process and Standards to lead a global team of CTAs, oversee TMF/eTMF systems, and drive process improvements in alignment with ICH/GCP standards. The role partners with quality to ensure inspection readiness and engages with IT for system roadmaps and changes.

In this senior position, you will shape clinical operations strategy, define best practices, and mentor teams across trials and programs to ensure high-quality, compliant delivery in a fast-paced

Qualifications

• 15+ years progressive experience in clinical operations.
• 5 years in a managerial role or equivalent.
• Excellent knowledge of ICH/GCP and regulatory guidelines.

Responsibilities

• Lead a global team of CTAs and manage operational tasks for clinical trials.
• Oversee TMF and TMF-related processes to ensure inspection readiness.
• Oversee CTMS/eTMF system maintenance and improvements with IT alignment.
• Develop and improve training materials and study-level training tools.
• Serve as BPO for CTMS/eTMF and ensure risk/change management for system implementations.

Skills

Leadership

Strategic planning

Inspection readiness

Regulatory compliance

Cross-functional collaboration

Change management

Education

Bachelor's degree in Life Sciences

Tools

CTMS

eTMF

GCP/ICH knowledge

Job description

Galderma is seeking a Head of Clinical Process and Standards to lead a global team of CTAs, oversee TMF/eTMF systems, and drive process improvements in alignment with ICH/GCP standards. The role partners with quality to ensure inspection readiness and engages with IT for system roadmaps and changes.

In this senior position, you will shape clinical operations strategy, define best practices, and mentor teams across trials and programs to ensure high-quality, compliant delivery in a fast-paced