About this role
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