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Clinical Trial Manager
Japan Tokyo, Tokyo Tokyo JP
Job Description
Start Date: Flexible, aligned to candidate availability
Location: Remote (Japan / APAC-aligned)
Company Overview
The client is a global pharmaceutical organisation with a strong focus on clinical development across early- and late-phase studies. The organisation operates to high standards of quality, compliance, and operational excellence, delivering trials across multiple therapeutic areas and regions.
Role Summary
The Clinical Trial Manager is responsible for supporting and/or leading the planning, set-up, and execution of assigned clinical trials, including interventional and non-interventional studies across different stages of development.
The role works closely with cross-functional internal teams and external vendors to ensure trials are executed efficiently, compliantly, and to agreed timelines, budgets, and quality standards. The position operates in a matrix environment, has no direct reports, but provides oversight and direction to trial team members and vendors.
Key Responsibilities
- Manage day-to-day operations for assigned clinical trials in compliance with GCP / ICH and applicable regulatory requirements
- Lead or support cross-functional trial teams, including external vendors
- Maintain accurate and up-to-date trial information within tracking systems and provide regular status updates to stakeholders
- Proactively identify, manage, and escalate trial-related risks and issues
- Support or lead development of core trial documents, trial plans, and system set-up
- Contribute to protocol preparation and implementation of standards, processes, and systems to ensure quality across sites, vendors, and data
- Support vendor selection, scope definition, and ongoing vendor management
- Participate in feasibility assessments and selection of countries and sites
- Support site engagement and communication to achieve trial milestones
- Oversee clinical aspects of data cleaning, data review, and availability of topline results
- Support investigator and site monitor training, including operational and therapeutic area training
- Provide oversight and direction to trial team members for assigned deliverables
- Manage clinical trial budgets and associated vendor contracts, including tracking in relevant systems
- Ensure quality, completeness, and inspection readiness of the Trial Master File (TMF)
- Participate in inspection readiness activities and audits as required
- Support evaluation and implementation of patient-focused strategies where applicable
- Manage timelines, resources, and trial-level deliverables for assigned studies
Qualifications
Required
- Bachelor’s degree with 3+ years of clinical trial experience, or
Advanced degree (MS / PhD / PharmD) with 2+ years of clinical trial experience - Strong knowledge of ICH / GCP guidelines and regulatory requirements
- Working knowledge of clinical trial design, planning, execution, and monitoring
- Demonstrated project management and trial leadership capability
- Excellent interpersonal, written, and verbal communication skills
- Strong administrative and computer skills
- Fluent in English
- Willingness to travel approximately 25%
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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