Clinical Study Specialist

Regeneron Pharmaceuticals, Inc.; Armonk (NY, NJ); Hybrid; USD 75,000 - 105,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. in Armonk, NY (or Warren, NJ) seeks a Clinical Study Specialist to join our Clinical Trial Management team. You will provide technical and administrative support to study teams, helping ensure trials stay on track from site activation through close-out.

The role collaborates with Clinical Study Leads, CROs, and study sites. A bachelor’s degree and 2+ years of industry experience, plus familiarity with trial management systems and MS Office, are required.

Qualifications

• 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.

Responsibilities

• Organizes and delivers analyzable reports and metrics, and coordinates study team meetings, agendas, and minutes.
• Tracks site activation, enrollment, and monitoring visits against projected plans, escalating issues or delays.
• Performs TMF reconciliations and ensures timely receipt of scheduled reports (e.g., 1572s, financial disclosures).
• Communicates with sites and maintains site contact information and relationships.
• Contributes to close-out activities and oversight of third-party vendors as needed.
• Participates in SOP revisions and departmental initiatives to improve processes.

Skills

Trial management systems

MS Office

Medical terminology

ICH/GCP awareness

Deadline management

Education

Bachelor's degree in life sciences or related field

Job description

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. In this role, you will provide technical and administrative support to clinical study teams executing trials across a program, helping ensure studies stay on track from site activation through close-out, while collaborating with Clinical Study Leads, Clinical Study Associate Managers, CROs, and study sites.

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

• Location: Armonk, NY or 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. 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.

What people ask before they join

We take hiring seriously — because finding the right person for our mission matters as much to us as finding the right company matters to you. Our process is thorough by design: we want every new hire to feel confident they've found a place where their work truly matters, and we want to be just as confident we've found someone who'll thrive here. It's a two-way conversation, not a one-way interview.

Curious what that looks like step by step? Check out How We Hire .

Part of the team

Where You'll Make an Impact

Here, you’ll collaborate with teams across regions to help move our mission forward.

We invest in your health and stability so you can focus on making meaningful impact. Below is a highlight of benefit programs that may be available to you, depending on your country of employment, role, etc.

Medical, dental and vision insurance

Life insurance and disability coverage

Global wellness support & benefits access

Paid time off, personal/flexibility hours and holiday leave

Showing slide 1 of 4 (group 1 of 2)

How We Hire

Our hiring process

From application to your first day — here's how it works.

1. EXPLORE

Browse open roles at careers.regeneron.com, filtered by department, location or category. You can also create a job alert or join our Talent Community to get matched with new openings as they post.

2. APPLY

See something you like? Submit your application for the role that fits your background and goals.

3. CONNECT

We review your application and if your experience is a match, we'll reach out to start the conversation. Some roles include a seminar or technical exercise — we'll always tell you in advance.

4. DECISION

After interviews and careful consideration by the hiring team, we'll follow up either way. If you're selected, we'll walk you through the offer — compensation, benefits, and start date.

5. WELCOME

Once you accept, we'll help you prepare for day one - from paperwork and office details to relocation when applicable. You'll have the support you need to start strong.

Stay connected

Be part of what’s next in science

Hear about new opportunities and stories across our teams.