Clinical Trial Manager/ノンラインマネージャー/医薬開発本部クリニカルディベロップメントオペレーションズジャパンクリニカルトライアルマネジメント第１グループ

Basic Purpose of the Job

The Clinical Trial Manager (CTM) is accountable for the operational and scientific oversight, set-up, execution and delivery of assigned clinical trials at the Japan level.

Key responsibilities:

• Accurate planning and efficient trial execution
• Provide leadership to Japan trial teams
• Ensure delivery aligned with milestones and KPIs (e.g. MedEx)
• Manage trial planning, implementation, tracking, and risk mitigation
• Liaise with Clinical Trial Leader (CTL) and stakeholders
• Communicate trial status and escalate issues

Senior CTM (G5):

• Expert in clinical operations
• Guide and mentor junior CTMs
• Act as delegate of Country Trial Management Lead
• Co-lead non-trial initiatives
• May act as CTL for standalone Japan trials

Accountabilities

1. Trial Preparation

• Ensure compliance with ICH-GCP, regulations, SOPs, and protocol
• Manage and review Japan trial budget
• Ensure training for internal and external partners
• Plan timelines and coordinate feasibility
• Validate site selection and patient commitment
• Develop recruitment, engagement, and risk mitigation plans
• Coordinate patient-facing materials
• Oversee vendor outsourcing
• Respond to Regulatory Authority/Ethics Committee inquiries

Performance Indicators:

• Adherence to MedEx KPIs
• Timely TMF documentation
• Updated trial systems
• Effective communication
• Patient-centric initiatives implemented

2. Trial Conduct

• Maintain GCP and regulatory compliance
• Monitor risks and mitigation
• Oversee budget and quality monitoring
• Track patient recruitment progress
• Support investigator meetings
• Maintain relationships with sites, experts, and stakeholders
• Participate in CD&O network

Performance Indicators:

• Compliance maintained
• Budget monitored
• Trial oversight meetings documented
• Core documents available on time
• Timely responses to authorities
• Vendor continuity ensured
• Trial targets achieved

3. Trial Closeout and Reporting

• Ensure timely data cleaning and delivery
• Archive documents in TMF
• Submit CTR to authorities
• Share results with sites and patients

Performance Indicator:

• Timeline adherence (e.g. database lock targets)

4. General Accountabilities

• Maintain engagement with investigators and patient organizations
• Ensure cross-functional collaboration
• Support CTL and escalation processes
• Contribute to Japan clinical development team (JCDT)
• Provide early input into CDP/TDO

G5 Additional:

• Lead initiatives within CD&O
• Represent organization externally
• Support CTM oversight and resolve complex issues

Leadership Competencies

• Inspire and empower teams
• Foster learning culture
• Encourage innovation and smart risk-taking
• Promote CD&O identity

G5:

• Co-lead with Country Trial Management Lead
• Embed empowerment culture

Regulatory / Organizational Requirements

• Follow BI SOPs, business practices, and regulations
• Maintain high ethical standards
• Deliver quality work aligned with BI values

Job Complexity

• Lead trial execution in Japan
• Ensure patient safety and data integrity
• Coordinate global, cross-functional teams
• Manage regulatory and ethical complexity
• Engage with external stakeholders

Interfaces