Senior Clinical Trials Lead — Global Study Management

Neurocrine Biosciences; England; Sur place; GBP 85 000 - 110 000; Plein temps

Résumé du poste

Neurocrine Biosciences in the United Kingdom is seeking a Clinical Operations Lead to oversee planning, start-up, conduct and close-out of domestic and global studies, including CRO management.

You will ensure studies comply with FDA, ICH, GCP and EU directives, lead study teams, develop timelines, manage CSPs and monitor vendors, delivering with cross-functional partners.

Excellent project management and communication skills are essential to drive trial execution on time and within budget.

Qualifications

• BS/BA degree with 6+ years in clinical trial management.
• Master’s degree with 4+ years in clinical operations.
• Knowledge of FDA regulations, ICH and GCP.

Responsabilités

• Ensure studies are conducted per FDA, EU, ICH and SOPs.
• Serve as primary contact for clinical operations on assigned studies.
• Participate in design discussions and provide input to protocols and study reports.
• Manage CROs and CSPs for assigned studies.
• Lead study team meetings and develop timelines; identify enrollment barriers.
• Monitor internal studies; develop monitoring plans and perform on-site visits.
• Collaborate to implement and enforce standard processes across programs.
• Perform other duties as assigned.

Connaissances

Clinical trial management

CRO/vendor management

Budget monitoring

FDA regulations

ICH/GCP knowledge

EU Directive knowledge

Leadership

Project management

Communication skills

Analytical thinking

Formation

BS/BA + 6+ years

Master’s + 4+ years

Description du poste

Neurocrine Biosciences in the United Kingdom is seeking a Clinical Operations Lead to oversee planning, start-up, conduct and close-out of domestic and global studies, including CRO management.

You will ensure studies comply with FDA, ICH, GCP and EU directives, lead study teams, develop timelines, manage CSPs and monitor vendors, delivering with cross-functional partners.

Excellent project management and communication skills are essential to drive trial execution on time and within budget.