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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.

All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.