Clinical Trial Manager (Biotech)

TL;DR

Clinical Trial Manager (Global Ph2b-3): Management and oversight of global phase I-IV clinical trials from startup through CSR with an accent on protocol adherence, vendor management, and budget control. Focus on coordinating cross-functional teams, monitoring study metrics, and ensuring compliance with GCP and regulations.

Location: Based out of Tokyo office with weekly flexibility (hybrid). Occasional domestic/international travel (approx. 25%).

Company

Global biopharmaceutical company dedicated to transforming lives of patients with serious and rare diseases.

What you will do

• Lead and coordinate management and execution of all clinical trial activities in compliance with GCP and regulations.
• Oversee regional trial activities and manage third-party suppliers to meet quality, cost, and timeline deliverables.
• Manage cross-functional clinical study teams to achieve high-quality deliverables on time and within budget.
• Monitor study metrics, develop project plans, and provide status updates to senior management.
• Ensure vendors adhere to contracts, handle change orders, and coach/mentor program staff (CRAs, CTAs).
• Collaborate with clinical scientists and teams on patient profiles, data review, and resource planning.

Requirements

• Bachelor's degree in life sciences, healthcare, or related field.
• Minimum 7+ years of clinical trial management experience in pharmaceutical/biotech industry.
• Minimum 2+ years indirect management experience, including coaching/mentoring.
• Experience managing global, large/complex studies and global CROs/specialty vendors required; rare disease/orphan indications preferred.
• Thorough understanding of drug development, ICH/GCP, and local regulations.
• Strong leadership, critical thinking, communication, and organizational skills in matrixed environment.

Nice to have

• Experience in rare disease and/or orphan indications.

Culture & Benefits

• Hybrid work environment with flexible hours and comprehensive vacation policy.
• Attractive compensation including retirement plans, stock rewards, and employee stock purchase program (ESPP).
• Career development via internal/external training, LinkedIn Learning, and specialized programs.
• Advanced learning tools with AI support and digital assistants for resources.
• Global recognition programs and employee resource groups.
• Modern Tokyo office with free-address system, cafe collaboration spaces, and advanced tech for seamless global teamwork.