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:
- Coordinate and manage project start-up, project maintenance, and project close-out activities;
- Maintain ongoing Sponsor contact for project-specific issues by serving as primary contact for Sponsor and all project team members;
- Track study status including patient status, Case Report Form status, safety issues, timelines, etc.;
- Serve as primary contact for protocol interpretations and logistical project-related issues (internal and external);
- Provide management oversight for Clinical Research Associates and Project Coordinators on project team;
- Interpret contract-related issues and coordinate Medpace activities according to current scope;
- Develop study management tools, including communication plan, clinical monitoring plan, patient recruitment and retention plan;
- Communicate change in scope to Sponsor clinical team and Medpace Contract Manager.
- Provide input for following (when applicable):
- Study protocol
- Edit Check Specifications
- Data Analysis Plan
- Data clean-up results
- Analysis
- 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);
- Broad knowledge of medical terminology, clinical patient management, and clinical research methodology;
- Bilingual Japanese and English
Medpace Overview
Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV 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 its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 6,000 people across 40 countries.
Why Medpace?
People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.
The work we've done over the past 30 years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.
Medpace Perks
- Flexible work environment
- Competitive compensation and benefits package
- Structured career paths with opportunities for professional growth
- Company-sponsored employee appreciation events
- Employee health and wellness initiatives
Awards
- Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
What to Expect Next
A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
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