Clinical Study Specialist

Build our future together:

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Clinical Study Specialist to join our clinical study team, supporting our Japan business in a hybrid work mode. In this role, you will 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.

When & where:

Tokyo, Japan.

Hybrid.

Travel may be required up to 25%.

Discover your role:

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.

You 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.

This role requires:

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.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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.

Where necessary, we disclose salary ranges for roles in all countries in which we operate.  The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits.  Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: 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, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/ . For other locations, additional information will be provided during the recruitment process.  If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.