Basic Purpose of the Job

The Clinical Trial Manager (CTM) is responsible for operational and scientific oversight, set-up, execution, and delivery of assigned clinical trials at the Japan level. The CTM ensures accurate planning and efficient execution aligned with milestones and KPIs (e.g., MedEx).
They lead the Japan trial team, manage engagement with internal/external stakeholders, and ensure compliance with global/local requirements.

The Senior CTM (G5) additionally:

• Acts as a delegate of the Country Trial Management Lead

• Guides and mentors junior CTMs

• Co-leads non-trial work toward Medicine Excellence

• May act as CTL for standalone Japan trials

• Ensures trial planning, conduct, reporting, risk mitigation, and team leadership

Accountabilities

1. Trial Preparation

Responsible for all preparation activities in Japan, including:

• Ensuring compliance with ICH-GCP, regulations, SOPs

• Creation and management of Japan trial budget

• Trial-specific training for internal/external partners

• Feasibility planning and timeline oversight

• Site selection and validation with cross-functional collaboration

• Development of recruitment and patient engagement plans

• Vendor management and outsourcing

• Responding to Health Authorities/Ethics Committees

• Facilitating trial efficiencies and frontloaded activities

Performance Indicators:

• MedEx timeline adherence

• Timely TMF filing

• System updates

• Effective team communication

• Implementation of patient-centric initiatives

2. Trial Conduct

• Maintaining oversight of trial execution and compliance

• Budget oversight and mitigation

• Monitoring recruitment and actions for contingencies

• Supporting investigator meetings

• Building relationships with external experts, sites, patient groups

• Cross-functional coordination

• Active participation in CD&O community

Indicators:

• Compliance fulfillment

• Reporting/mitigation of budget deviations

• Oversight documentation

• Timely document availability

• Vendor performance management

• Meeting trial commitments

3. Trial Closeout and Reporting

• Ensuring timely data cleaning and delivery

• TMF archiving of Japan-level documents

• CTR submissions to regulators/ECs

• Sharing trial results with sites and patients

Indicators:

• Achieving timelines and MedEx targets for database lock

General Accountabilities

• Build engagement with investigators, site staff, and Patient Organizations

• Maintain cross-functional collaboration (Medical, Market Access, PAR)

• Support CTL with issue escalation

• Represent CD&O Japan in clinical development team activities

• Provide input to trial design and CDP from Japan perspective

G5 Additional:

• Lead CD&O initiatives

• Represent CD&O in industry associations

• Act as delegate of Country Trial Management Lead

Leadership Competencies

• Inspire and motivate colleagues, fostering common CD&O identity

• Promote learning culture and innovation

• Encourage empowerment and smart risk-taking

• Effective communication, teamwork, and visionary thinking

Regulatory & Organizational Requirements

• Ensure all work complies with BI SOPs, Business Practices, HTGs, and regulations

• Maintain ethical and professional standards

• Deliver high-quality work with focus on speed and patient value

Job Complexity

• Functional leadership of Japan trial team

• Coordination across global and local teams, CROs, vendors

• Maintaining integrity, patient safety, and regulatory compliance

• Engagement with investigators, POs, regulators

• Contribution to feasibility and digital trial innovations

G5: Increased complexity depending on delegated tasks.

Interfaces

Collaboration with:

• CD&O teams

• Medical functions

• HP functions (incl. patient advocacy)

• CROs and external suppliers

• Investigators and site staff

• Research networks

• Patient organizations

Job Expertise Requirements

• Strong clinical trial project management

• Understanding of regulations in Japan

• Experience with CROs and POs desirable

• TA experience desirable

• Strong communication, relationship-building skills

Job Impact

• Accelerates delivery of innovative therapies

• Ensures adherence to KPIs, quality, and budgets

• Safeguards patient safety and data integrity

• Supports trial oversight at Japan level

Minimum Education

• University degree (Master’s or comparable)

• Biomedical/Life Sciences background desirable

Required Capabilities

Communication – AAI approach, cultural awareness
Scientific & Operational Expertise – Protocol, sites, vendors, logistics
Leadership & Influence – Vision, empowerment, decision-making
Strategic Mindset – Future-focused, innovative
Coordination & Oversight – Prioritization, resource optimization
Project Management – Planning, problem-solving, risk management

G5: Ability to manage highly complex, large-scale trials.