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Bristol Myers Squibb is seeking a Clinical Research Associate (CRA) in Japan to oversee clinical trial progress, ensuring compliance with protocols, SOPs, and regulatory requirements. The role requires collaboration with various stakeholders, site evaluations, and monitoring activities, with an emphasis on maintaining data integrity and ensuring participant safety.
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Job Summary
The role involves ensuring clinical trials are conducted in accordance with protocols, SOPs, GCP, and applicable regulatory requirements while protecting subject safety.
Candidates will act as a primary point of contact for study sites, managing relationships with investigators and facilitating site selection and activation processes.
Bristol Myers Squibb offers a flexible work environment with competitive benefits designed to support employees' professional growth and personal well-being.
Matching Summary
Match Score: 75
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Bristol Myers Squibb is seeking a Clinical Research Associate (CRA) in Japan to oversee clinical trial progress, ensuring compliance with protocols, SOPs, and regulatory requirements. The role requires collaboration with various stakeholders, site evaluations, and monitoring activities, with an emphasis on maintaining data integrity and ensuring participant safety.
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Skills & Requirements
Must-have
ICH/GCP Guidelines knowledge
Site initiation and monitoring visits
Electronic Data Capture (eDC) systems
Protocol adherence and compliance
Risk-based monitoring approach
Stakeholder relationship management
Nice-to-have
Leadership and mentoring capabilities
Experience with Investigator Sponsored Studies
Strong verbal and written communication skills
Ability to work under pressure
Cross-functional collaboration experience
Key Requirements
Bachelor's degree in Life Sciences or equivalent
1-5 years of relevant clinical research experience depending on level
Fluency in English and Japanese languages
Proficiency with CTMS, eDC, and eTMF systems
Willingness to travel according to monitoring plans