Clinical Study Associate, Clinical Operations

Regeneron UK Limited; Uxbridge; Hybrid; GBP 32,000 - 52,000; Full time

Job summary

Regeneron UK Limited is seeking a Clinical Study Associate, Clinical Operations to support multiple trials from our Hybrid Uxbridge office. The role involves ensuring compliance with SOPs, GCP, ICH guidelines, and regulations, plus coordinating study team meetings and essential document workflows.

The ideal candidate has 0-1 year of relevant experience, a life sciences degree, and familiarity with CTMS/eTMF systems to maintain accurate trial data and regulatory submissions.

Qualifications

• Bachelor's degree preferred in life sciences or related field.
• 0-1 year of relevant clinical operations experience.
• Knowledge of GCP, ICH guidelines, and applicable regulations.
• Experience reviewing study documentation and eTMF.
• Familiarity with CTMS and clinical reporting tools.

Responsibilities

• Support multiple clinical trials while ensuring SOPs, GCP, ICH guidelines and regulations.
• Coordinate study team meetings, 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 submissions.
• Maintain data in CTMS and monitor study disclosure requirements.
• Track study closeout activities, reports and CRA closeout visits.

Skills

GCP knowledge

ICH guidelines

CTMS familiarity

Regulatory documentation

Coordination

Collaboration across teams

Education

Bachelor's degree in life sciences or related field

Associate degree considered

Tools

CTMS

eTMF

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.

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.

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.

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.

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.