Clinical Study Specialist (Internal Medicine)

Regeneron Pharmaceuticals, Inc.; Kentucky; On-site; USD 70,000 - 95,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Clinical Study Specialist to join its Clinical Trial Management team.

You will provide technical and administrative support across trials from site activation through close-out, collaborating with trial leads, CROs, and study sites. The role requires a Bachelor's degree with 2+ years in a clinical setting, familiarity with trial management systems and MS Office, and knowledge of ICH/GCP.

Qualifications

• Bachelor's degree in a related field with 2+ years of industry experience in a clinical setting.
• Familiarity with trial management systems and MS applications (PowerPoint, Word, Excel, IVRS/IWRS, EDC, TMF).
• Knowledge of ICH/GCP and clinical drug development terms.

Responsibilities

• 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.

Skills

Clinical study experience

Trial management

MS Office proficiency

ICH/GCP knowledge

Deadline management

Education

Bachelor's degree

Tools

PowerPoint

Word

Excel

IVRS/IWRS

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. 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.

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

Salary & Benefits

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.

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.

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 a