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Clinical Trial Manager/ノンラインマネージャー or スタッフ/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

Works with:

  • CD&O and medical functions
  • HP functions (including patient advocacy)
  • CROs and suppliers
  • Investigators and site staff
  • Research networks
  • Patient organizations

Job Expertise

  • Strong clinical trial project management experience
  • Knowledge of project management and teamwork
  • Understanding of Japan regulations
  • Experience with CROs and patient organizations (preferred)
  • Strong communication and influencing skills

Job Impact

  • Accelerate delivery of therapies
  • Ensure compliance and quality
  • Safeguard patient safety and data integrity
  • Manage risks at Japan level

Minimum Education

  • University degree (e.g. Master’s) in relevant field
  • Biomedical Life Sciences preferred

Required Capabilities

Communication

  • Strong cross-functional communication
  • Cultural awareness and active listening

Scientific & Operational Expertise

  • Knowledge of trial planning and execution
  • Understanding of protocol, sites, patients, vendors

Leadership & Influence

  • Ability to lead teams and set direction
  • Inspire and align teams

Strategic Mindset

  • Future-oriented, analytical, innovative
  • Integrates study and portfolio strategy

Coordination & Oversight

  • Strong prioritization and resource management

Project Management

  • Planning, execution, transparency
  • Risk anticipation and resolution

G5:

  • Manage complex, large-scale trials
  • Handle multiple trials simultaneously

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