Clinical Affairs Specialist – Tokyo, Japan
Location: Tokyo, Japan
Category: Medical & Clinical Affairs
Experience Required: Minimum 1 year in clinical research or medical affairs
About the Role
We are seeking a Clinical Affairs Specialist to join our Medical Affairs team in Tokyo. This is a key individual contributor role that applies specialized knowledge to support clinical trials, research initiatives, and medical strategy execution under limited supervision.
The Clinical Affairs Specialist will play a pivotal role in clinical operations, investigator engagement, protocol implementation, and regulatory reporting to ensure the success of company-sponsored clinical studies.
Key Responsibilities
Oversee the planning, execution, and monitoring of clinical trials (Phases III & IV) and research initiatives.
Contribute to the implementation of clinical protocols and ensure the completion of final study reports.
Recruit and manage clinical investigators, including negotiation of study designs, budgets, and timelines.
Monitor adverse events and patient safety, ensuring compliance with company and regulatory standards.
Coordinate reporting activities for submissions to regulatory agencies.
Track protocol adherence and determine study completion milestones.
Manage investigator initiations and group studies, providing guidance and operational oversight.
Serve as a consultant or liaison with external partners under licensing agreements when required.
Participate in continuous improvement initiatives for clinical processes and trial efficiency.
Qualifications
Education:
Associate’s degree or equivalent (13 years of formal education minimum).
Experience:
Minimum 1 year of experience in clinical research, medical affairs, or healthcare-related studies.
Skills & Competencies:
Strong understanding of clinical trial operations and regulatory requirements.
Ability to manage multiple tasks under limited supervision.
Excellent communication and collaboration skills for working with internal and external stakeholders.
Proficiency in data collection, reporting, and documentation related to clinical studies.
Why Join Us
Work with a global healthcare leader committed to improving patient outcomes.
Gain experience in cutting-edge clinical research and medical affairs initiatives.
Access opportunities for career development, professional growth, and cross-functional collaboration.
Be part of a dynamic team in Tokyo, contributing to life-changing healthcare solutions worldwide.
Apply Now to advance your career as a Clinical Affairs Specialist in Japan and play a vital role in supporting clinical research, regulatory compliance, and medical excellence.
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