Clinical Study Specialist

Regeneron Pharmaceuticals, Inc (USA); Village of Tarrytown (NY); Hybrid; USD 94,000 - 153,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. seeks a Clinical Study Specialist to join our Clinical Trial Management team in Armonk, NY.

The role centers on delivering analyzable reports, coordinating study meetings, and tracking site activation and enrollment to keep trials on schedule. You will work primarily on-site with hybrid flexibility, requiring a Bachelor's degree and 2+ years in a clinical setting, familiarity with trial systems, ICH/GCP, and proactive, deadline-driven collaboration with internal

Qualifications

• Bachelor's degree with 2+ years of clinical industry experience.
• Ability to learn trial management systems and MS applications.
• Familiarity with medical terms and clinical drug development.
• Awareness of ICH/GCP.
• Proactive with deadlines and priorities.

Responsibilities

• Organizes and delivers analyzable reports and metrics.
• Coordinates study team meetings, agendas, minutes.
• Tracks site activation, enrollment, monitoring against plans.
• Ensures timely receipt of reports and TMF reconciliations.
• Communicates with sites and maintains relationships.
• Supports close-out activities and oversight of vendors.
• Suggests process improvements and SOP revisions.

Skills

Study management

Report generation

Timelines management

Education

Bachelor's degree

Tools

Microsoft Project

PowerPoint

Word

Excel

EDC

TMF

Job description

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 Trial Management team.

When & where:

Location: Armonk, NY, Warren, NJ. Work Model: Primarily on-site with hybrid flexibility.

Discover your role:

• Organizes and delivers analyzable reports and metrics, and coordinates study team meetings, agendas, and minutes
• Collates data for feasibility and site selection assessments, and contributes to review of study documents (e.g., informed consent forms, case report forms) and reference materials (e.g., regulatory, pharmacy, laboratory binders)
• Tracks site activation, enrollment, and monitoring visits against projected plans, escalating issues or delays, and monitors investigator/site status and registry postings
• Ensures timely receipt of scheduled reports (e.g., 1572s, financial disclosures) and performs TMF reconciliations with study lead guidance
• Communicates with sites as directed, maintaining site contact information and strong relationships internally and externally
• Contributes to close-out activities (e.g., 1572s, IP reconciliation, financial disclosures, CRA close-out visits) and supports oversight of third-party vendors as needed
• Brings attention to detail, resourcefulness, and proactive problem-solving to assigned study activities, investigating impact on trials as new information arises
• Participates in SOP revisions and departmental initiatives, proactively recommending process improvements

This role requires:

• Bachelor's degree with 2+ years of industry-related work experience in a clinical setting
• Ability to acquire working knowledge in trial management systems and MS applications (Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC, TMF)
• Basic familiarity with medical terms and clinical drug development
• Awareness of ICH/GCP
• Proactive, self-disciplined, and effective at managing deadlines and priorities

Does this sound like you?

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.

Please be advised that at Regeneron, we believe we do our best work when we are together.

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.

Salary Range (annually) $93,900.00 - $153,300.00

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.