Clinical Affairs Specialist

JOB DESCRIPTION:
About Abbott
Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:
Career development with an international company where you can grow the career you dream of.
A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
MAIN PURPOSE OF THE ROLE
Experienced professional individual contributor that works under limited supervision.
Applies subject matter knowledge in the area of Clinical Research.
Requires capacity to apply skills/knowledge within the context of specific needs or requirements in site management, including oversight of contract CRAs and mentoring of less experienced CRAs.
MAIN RESPONSIBILITIES
• As the experienced professional CRA, possesses well-developed skills in overseeing the monitoring, planning, execution of clinical trials/research, and data collection activities.
• Contributes to implementation of clinical protocols.
• Recruits clinical investigators and negotiates study costs with clinical sites.
• Responsible for directing human clinical trials, pre- and post-marketing trials, PMS, and clinical research activities.
• Monitors compliance with protocols, J-GCP, GPSP, and SOPs.
• Manages and oversees contract/temporary CRAs to ensure study activities are executed in compliance with protocols, SOPs, regulations, and study timelines.
• Provides day-to-day guidance, performance oversight, and workload management for contract/temporary CRAs, including issue escalation and resolution.
• Mentors and supports junior and less experienced CRAs through coaching, training, and regular feedback to enhance monitoring quality, productivity, and professional development.
• Facilitates knowledge sharing and promotes best practices across the CRA team to drive consistency and continuous improvement in monitoring activities.
• May participate in adverse event reporting and safety monitoring responsibilities.
• May act as a consultant and liaison with clinical sites.
Education
Bachelor’s degree or above
Experience/Background
Minimum 3 year experience as a CRA in the healthcare sector.
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is
N/A
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Medical & Scientific Affairs
DIVISION:MD Medical Devices
LOCATION:Japan > Tokyo : Hamarikyu Park Side Place 9F, 17F 5-6-10,Tsukiji,Chuo-ku
ADDITIONAL LOCATIONS:
WORK SHIFT:Standard
TRAVEL:Not specified
MEDICAL SURVEILLANCE:Not Applicable
SIGNIFICANT WORK ACTIVITIES:Not Applicable