Job Summary :
Medpace is the leading CRO for biotech companies and is continuing to add leaders to join our Clinical Trial Management team in Japan. Clinical Trial Management leaders with expertise in Oncology/Hematology, Cardiovascular, Infectious Disease, CNS, Neuroscience, Immunology, and more are welcome to continue to work in their area of expertise, or to expand to a new therapeutic area of our focus. The Clinical Trial Manager (CTM) position performs as project lead for multiservice clinical trials (some global in scope). The position interacts with sponsors and manages the timeline and all project deliverables. This role coordinates all services contracted for the study. CTMs are also responsible for leading a team of CRAs and managing project coordinators.
Responsibilities :
- Effective Management of a project including:
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Coordinate and manage project start-up, project maintenance, and project close-out activities;
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Maintain ongoing Sponsor contact for project-specific issues by serving as primary contact for Sponsor and all project team members;
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Track study status including patient status, Case Report Form status, safety issues, timelines, etc.;
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Serve as primary contact for protocol interpretations and logistical project-related issues (internal and external);
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Provide management oversight for Clinical Research Associates and Project Coordinators on project team;
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Interpret contract-related issues and coordinate Medpace activities according to current scope;
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Develop study management tools, including communication plan, clinical monitoring plan, patient recruitment and retention plan;
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Communicate change in scope to Sponsor clinical team and Medpace Contract Manager.
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Provide input for following (when applicable):
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Study protocol
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Edit Check Specifications
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Data Analysis Plan
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Data clean-up results
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Analysis
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Final study report
Qualifications :
- Bachelor’s degree and 4 years related pharmaceutical industry experience (clinical monitoring or study management), or Master's degree/PhD with 2 years of related pharmaceutical industry experience (clinical monitoring or study management);
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Broad knowledge of medical terminology, clinical patient management, and clinical research methodology;
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Bilingual Japanese and English
Medpace Overview :
Medpace is a full-service clinical contract research organization (CRO) providing phase l-lV clinical development services to the biotechnology, pharmaceutical, and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through the advancement of clinical research. We leverage in-country regulatory and therapeutic expertise across all major therapeutic areas including oncology, cardiology, metabolic, endocrinology, central nervous system, and anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, we employ more than 6,500 people across 40+ countries.
Why Medpace? :
When you join Medpace, you become part of an innovative team that brings cutting-edge therapies to market while building a meaningful and rewarding career focused on scientific excellence and improving patient outcomes around the world through continuous learning and cross-functional collaboration.
Purpose-Driven Work
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Work alongside physicians, scientists, and industry-leading experts committed to advancing the global development of medical therapeutics through clinical research excellence
Collaborative Culture
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Contribute to an interactive team environment that empowers decision making, creative thinking, and continuous learning through open communication and mutual trust.
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Leadership throughout Medpace is both accessible and approachable
Continuous Growth & Development
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Office based environment with on-site mentors
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Defined career paths with clear advancement opportunities
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Industry renowned onboarding and training programs designed to accelerate professional development
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Ongoing training and continuous learning opportunities throughout your career
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An environment that encourages employees to influence change, contribute ideas, and grow quickly
Other Employee Benefits
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Competitive compensation programs that recognize and reward performance
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Comprehensive health, wellness, retirement, and PTO benefits
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Office based culture with occasional WFH that provides flexibility for eligible positions after training
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Company-sponsored social events
Please note benefits may vary based on country.
What to Expect Next
A Medpace team member will review your application and if your profile matches our current needs, you will be contacted for an interview. While we review all applications carefully, we are unable to respond to every applicant, and only candidates selected for interviews will be contacted.
