Clinical Study Specialist

About the role

Regeneron, a biopharmaceutical company developing medicines for serious diseases, is looking for a Clinical Study Specialist to join its clinical study team supporting the Japan business. The role is hybrid, based in Tokyo, with travel of up to 25% possible. You will support clinical trial execution while working with clinical study leads, sites and Clinical Research Organizations.

Key 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.

Required profile

• Bachelor's degree with 2+ years of relevant experience, or an associate degree with 5+ years of relevant experience.
• Awareness of ICH and Good Clinical Practice requirements.
• Basic familiarity with medical terminology and clinical drug development.
• 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.

Required skills

• Working knowledge of trial management systems and Microsoft applications (Project, PowerPoint, Word, Excel).
• Ability to learn IVRS/IWRS, EDC and Trial Master File systems.

The company states that many roles require on-site performance and that background checks may be carried out. It also describes a total rewards package that may include bonuses, equity, pension, 401(k) match, health and wellness programs, insurance, paid time off and family support, depending on country and role.