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About the Role
Support clinical trial execution while collaborating with clinical study leads, sites, and Clinical Research Organizations. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
Responsibilities
- Deliver analyzable study reports and metrics to clinical study leads.
- Coordinate study meetings, materials, minutes, training, and investigator meetings.
- Collate feasibility and site-selection data, reviewing site usability information.
- Review study documents and maintain version-controlled manuals under standard operating procedures.
- Track activation, enrollment, monitoring, site status, registry postings, reconciliations, required reports, and close-out activities.
- Proactively identify issues, investigate trial impacts, recommend improvements, and support departmental initiatives.
- Maintain SharePoint, shared drives, site contacts, line-listing reviews, and third-party vendor oversight.
Requirements
- Bachelor’s degree with 2+ years of relevant experience.
- Associate degree with 5+ years of relevant experience may substitute for a bachelor’s degree.
- Awareness of International Council for Harmonisation and Good Clinical Practice requirements.
- Basic familiarity with medical terminology and clinical drug development.
- Working knowledge of trial management systems and Microsoft applications, including Project, PowerPoint, Word, and Excel.
- Ability to acquire working knowledge of IVRS/IWRS, EDC, and Trial Master File systems.
- Attention to detail, problem-solving, prioritization, deadline management, and proactive information assessment.
- Strong communication and interpersonal skills, with resourcefulness, self-discipline, and relationship-building ability.
Skills
- Microsoft Project
- Microsoft PowerPoint
- Microsoft Word
- Microsoft Excel
- IVRS/IWRS
- EDC
- Trial Master File systems
Location
- Tokyo, Japan
Work Type
- Hybrid
- On-site
Experience Level
- 2+ years of relevant experience
- 5+ years of relevant experience
Education Level
- Bachelor’s degree
- Associate degree
Benefits
- Annual bonuses or other incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Insurance benefits (e.g. medical, dental, vision, life and disability)
- Paid time off
- Family support benefits
About the Company
- Regeneron uses science and innovation to develop life-changing medicines for people with serious diseases.
- We are committed to building a workplace with an inclusive culture.
Equal Opportunity
- Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law.
- Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.