Clinical Study Associate, Clinical Operations

Regeneron Pharmaceuticals, Inc; Uxbridge; Hybrid; GBP 28,000 - 42,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Clinical Study Associate, Clinical Operations in Uxbridge, UK. This hybrid, office-based position supports multiple trials while ensuring GCP/ICH compliance and strong study documentation practices.

The role emphasizes coordination, regulatory submissions, and collaboration across clinical study teams with entry-level experience preferred.

Qualifications

• Bachelor’s degree preferred; associate degree may be accepted.
• 0–1 year of relevant experience.
• Knowledge of GCP, ICH guidelines, and applicable regulations.
• Experience reviewing and maintaining study documentation and eTMF.
• Familiarity with CTMS and clinical reporting tools.
• Ability to coordinate study activities and regulatory submissions.
• Strong organizational skills with attention to detail and document quality.
• Ability to collaborate across clinical study teams and internal departments.

Responsibilities

• Support multiple clinical trials while ensuring GCP/ICH compliance.
• Participate in study team meetings and coordinate agendas, minutes, and logistics.
• Request, collect, review, and track site regulatory documents and start-up activities.
• Maintain, reconcile, and quality check essential documents and the eTMF.
• Support study reporting tools, monitoring visit schedules, investigator materials, and study binders.
• Manage Clinical Disclosure Agreements, consulting agreements, and internal review committee submissions.
• Maintain accurate data in CTMS and monitor trial disclosure requirements.
• Track study closeout activities, reports, financial requisitions, and CRA closeout visits.

Skills

Coordination

Regulatory documentation

Collaboration across teams

Attention to detail

Organizational skills

Education

Bachelor's degree preferred

Associate degree may be accepted

Tools

CTMS

eTMF

Clinical reporting tools

Job description

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Regeneron is currently seeking a Clinical Study Associate, Clinical Operations to join our Clinical Development team. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

Office based, Hybrid

Uxbridge, UK

What you’ll do:

• Support multiple clinical trials while ensuring compliance with Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and regulations.
• Participate in study team meetings and coordinate agendas, minutes, and logistics.
• Request, collect, review, and track site regulatory documents and start-up activities.
• Maintain, reconcile, and quality check essential documents and the electronic Trial Master File (eTMF).
• Support study reporting tools, monitoring visit schedules, investigator materials, and study binders.
• Manage Clinical Disclosure Agreements, consulting agreements, and internal review committee submissions.
• Maintain accurate data in the Clinical Trial Management System (CTMS) and monitor trial disclosure requirements.
• Track study closeout activities, reports, financial requisitions, and Clinical Research Associate (CRA) closeout visits.

Let’s find out if we’re a fit:

• Bachelor’s degree preferred; Associate degree may be accepted.
• 0-1 year of relevant experience.
• Knowledge of Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and applicable regulations.
• Experience reviewing and maintaining study documentation and electronic Trial Master Files (eTMF).
• Familiarity with Clinical Trial Management Systems (CTMS) and clinical reporting tools.
• Ability to coordinate study activities, regulatory documentation, and committee submissions.
• Strong organizational skills with attention to detail and document quality.
• Ability to collaborate across clinical study teams and internal departments.

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.

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. 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.