EU Clinical Operations Lead — Contractor

Get 360Pharma; Netherlands; Remote; EUR 90,000 - 120,000; Full time

Job summary

Get 360Pharma seeks an experienced Clinical Operations Lead to manage day-to-day activities of clinical studies, ensuring on-time milestones and GCP compliance. The role emphasizes EU submissions and cross-functional collaboration with Clinical Science, data management and statistics.

Responsibilities include study budgeting, vendor oversight (CROs, central labs), and ensuring study documents, CRFs, and TMF are developed, implemented and archived with high quality.

Qualifications

• Minimum 8 years' experience in clinical Operations management within biotech or pharma setting.
• Excellent organisational and communication skills; 'Can-do' attitude and flexibility.
• Experience overseeing external vendors (CROs, central labs, etc.).
• Understanding of regulatory environment, GCP/ICH, inspection readiness.
• Experience in orphan disease field is a plus.

Responsibilities

• Lead and coordinate conduct of assigned clinical trials from start-up to close-out per ICH-GCP.
• Oversee quality of clinical operations and ensure inspections readiness throughout study lifecycle.
• Manage study budgets, timelines and vendor relationships to meet deliverables.
• Collaborate with cross-functional teams (Clinical Science, data management, statistics) to ensure data integrity and study progress.
• Ensure development, review and delivery of study documents; manage CRFs and TMF.

Skills

Project management

GCP/ICH knowledge

Stakeholder collaboration

Regulatory understanding

Orphan disease knowledge

Education

BSc in life sciences

MSc/PhD in life sciences (plus)

Job description

Get 360Pharma seeks an experienced Clinical Operations Lead to manage day-to-day activities of clinical studies, ensuring on-time milestones and GCP compliance. The role emphasizes EU submissions and cross-functional collaboration with Clinical Science, data management and statistics.

Responsibilities include study budgeting, vendor oversight (CROs, central labs), and ensuring study documents, CRFs, and TMF are developed, implemented and archived with high quality.