Clinical Study Specialist

Regeneron Pharmaceuticals, Inc.; Warren (MI); Hybrid; USD 94.000 - 153.000; Vollzeit

Zusammenfassung

Regeneron Pharmaceuticals, Inc. is seeking a Clinical Study Specialist to join the Clinical Trial Management team in a role that supports trials from site activation through close-out.

You will organize reports, coordinate meetings, and manage documentation while collaborating with study leads, CROs, and sites. A bachelor's degree with 2+ years of clinical experience and strong MS Office skills are required, along with ICH/GCP awareness.

Qualifikationen

• Bachelor's degree and 2+ years of industry-related work experience in a clinical setting.
• Familiarity with trial management systems and MS applications (PowerPoint, Word, Excel, Project).
• Basic familiarity with medical terms and clinical drug development.
• Awareness of ICH/GCP.
• Proactive, self-disciplined, and able to manage deadlines and priorities.

Aufgaben

• Organizes and delivers analyzable reports and metrics, and coordinates study team meetings, agendas, and minutes.
• Collates data for feasibility and site selection assessments, and reviews study documents and reference materials.
• Tracks site activation, enrollment, and monitoring visits against plans, escalating issues as needed.
• Ensures timely receipt of scheduled reports and performs TMF reconciliations with guidance.
• Communicates with sites and maintains relationships internally and externally.
• Supports close-out activities and oversight of third-party vendors as needed.
• Proactively identifies process improvements and participates in SOP revisions.

Kenntnisse

Attention to detail

Deadline management

Communication skills

Clinical trial knowledge

Ausbildung

Bachelor's degree

Tools

MS Project

PowerPoint

Word

Excel

IVRS/IWRS

EDC

TMF

Jobbeschreibung

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.

When & where:

• Location: Armonk, NY, Warren, NJ, Cambridge, MA
• 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

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.

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