Clinical Study Lead - Clinical Trial Management

About the role

Regeneron, a biopharmaceutical company developing medicines for serious diseases, is looking for a Clinical Study Lead to join its Clinical Trial Management team and support its Japan operations. The role is hybrid, based in Tokyo, with up to 25% travel possible. You will lead assigned clinical trials from study design through close-out, working with cross-functional study teams, vendors and leadership.

Key responsibilities

• Lead cross-functional study teams and global, regional or country execution of assigned clinical trials
• Shape protocols, study documentation, feasibility, site selection, investigator meetings and recruitment strategies
• Manage timelines, budgets, risks, vendors, supplies, study systems, activation, monitoring and data quality
• Maintain the Clinical Trial Management System and Trial Master File readiness, including registry, audit and inspection compliance
• Escalate study issues and implement corrective actions with the Program Operations Lead, Country Operations Lead and stakeholders
• Lead close-out, including database lock, vendor reconciliation, budgets, Trial Master File and study drug accountability
• Support study reports, lessons learned, staff deliverables, process improvement, unmasked activities and potential line management

Required profile

• Bachelor's degree and at least six years of relevant industry experience
• Global clinical trial operations experience, including protocols, key study documents and budget and vendor management
• Knowledge of ICH GCP and applicable regulatory guidelines
• Project management, cross-functional leadership, organization, communication, influencing and negotiation skills
• Data-driven approach to planning, execution and problem-solving

Required skills

• Proficiency with trial management systems and electronic data capture
• Microsoft applications and Interactive Voice Response Systems

The company states that many roles require on-site performance and that background checks may be carried out. It also describes a total rewards package that may include bonuses, equity awards, pension or retirement benefits, 401(k) match, health and wellness programs, insurance benefits, paid time off and family support benefits, depending on country and role.