Regulatory Jobs
Hero Gradient Background
Two Regeneron scientists in lab coats working at bioreactors in a process development lab
Regeneron logo

New · posted Nov 1

Regeneron · Biotechnology

Clinical Study Specialist

  • Armonk, NY +1 more
  • Hybrid
  • Full-time
  • Associate & Specialist
Save
EmploymentFull-time
DeadlineOpen until filled

The role

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. 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.

What you need

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

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.

What you'll do

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

Pay and benefits

$93,900 – $153,300 a year

Employer provided
How this compares

$93,900.00 - $153,300.00

  • Annual bonuses or incentive plans

  • Equity awards

  • 401(k) company match

  • Health and wellness programs

  • Medical, dental, vision, life and disability insurance

  • Paid time off

Where you'll work

Armonk, NY +1 moreHybridOpen in Maps (opens in a new tab)

Also posted for: Warren, NJ

More jobs in Armonk, NY +1 more

Working conditions

When & where

  • Location: Armonk, NY or Warren, NJ
  • Work Model: Primarily on-site with hybrid flexibility
Equal opportunity, accessibility and legal noticesRegeneron's statements, word for word

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.

Job intelligence

The context around this role

Live data · November 1, 2026

Salary intelligence

How the pay compares

This role's midpoint is 42% above the US median for Clinical Trial Management roles at this level.

This roleEmployer provided

$93,900 to $153,300 a year

Associate & Specialist roles in the US6 roles publishing pay

Middle half $79,500 to $116,250, median $87,000
Annual base pay
Annual base payLowMedianHigh
This role$93,900—$153,300
All US$79,500$87,000$116,250

This role: Regeneron's own published range. Comparisons: the base pay employers published on open Clinical Trial Management roles at the same level on Regulatory Jobs, November 1, 2026. Nothing is estimated.

Career trajectory

Where this role sits in Clinical Trial Management

The general path across 69 open Clinical Trial Management roles on Regulatory Jobs, with the titles they carry most. Not Regeneron's own promotion track.

  1. This role

    Associate & Specialist

    Often: Clinical Trial Assistant · Clinical Study Specialist

    $87K median7 open
  2. Next step

    Senior & Principal

    Often: Regional Clinical Trial Management Senior Associate · Clinical Research Leader

    $131K median6 open
  3. Later

    Manager

    Often: Senior Clinical Trial Manager · Clinical Trial Manager

    $163K median55 open
  4. Later

    Director

    Often: Associate Director, Clinical Development Trial Lead

Skills DNA

What this role leans on

How many of the posting's 19 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.

GMP and compliance: 1 lineLab testing and methods: 1 lineDocumentation and SOPs: 4 linesInvestigations and CAPA: 2 linesQuality systems and risk: 1 lineData and digital systems: 1 lineClinical trial conduct: 5 linesCollaboration and leadership: 4 linesGMPLab testingDocumentationInvestigationsQuality systemsData systemsClinical trialsTeamwork
  • Clinical trial conduct5
  • Documentation and SOPs4
  • Collaboration and leadership4
  • Investigations and CAPA2
  • GMP and compliance1
  • Lab testing and methods1
  • Quality systems and risk1
  • Data and digital systems1

Company hiring pulse

Regeneron on Regulatory Jobs

163
Open roles
140
Distinct roles
11
Locations

By discipline

  • Clinical69 42%
  • Quality67 41%
  • Regulatory27 17%

By level

  • Associate & Specialist53 33%
  • Director49 30%
  • Manager46 28%
See all 163 Regeneron roles

More roles at Regeneron

All 163 Regeneron roles

Clinical Study Specialist at Regeneron

Open until filled. $94K–$153K a year, employer provided.

Job alerts