Clinical Study Specialist

Regeneron UK Limited; Uxbridge; On-site; GBP 40,000 - 65,000; Full time

Job summary

Regeneron is seeking a Clinical Study Specialist to join our Clinical Trial Management team in a hybrid role in Uxbridge. You will provide technical and administrative study support while collaborating with clinical study teams, sites, and third-party vendors.

You will deliver analysable study reports, coordinate meetings, collate data, maintain regulatory documents, track site activation and enrolment, and help ensure trial milestones are met.

Qualifications

• Bachelors degree or five years of relevant experience.
• At least two years of industry-related experience.
• An advanced related degree with one to two years of relevant experience is preferred.

Responsibilities

• Deliver analysable study reports and metrics to the Clinical Study Lead.
• Coordinate study meetings, agendas, presentations, minutes, training materials, and investigator meetings.
• Collate feasibility and site-selection data, including site usability database reviews.
• Facilitate document reviews and maintain version-controlled regulatory, pharmacy, and laboratory manuals.
• Track site activation, enrolment, monitoring visits, registry postings, and scheduled compliance reports.
• Reconcile the Trial Master File and track close-out documents, product reconciliation, and CRA visits.
• Maintain SharePoint sites, site contacts, BDRM line listings, and third-party vendor oversight.

Skills

Study management

Data analysis

Meeting coordination

Regulatory documentation

Education

Bachelor's degree

Advanced related degree

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, supporting our clinical trial execution in a hybrid role. In this role, you will provide technical and administrative study support while collaborating with clinical study teams, sites, and third-party vendors. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide. When & where: Uxbridge (Hybrid)

Discover your role:

• Deliver analysable study reports and metrics to the Clinical Study Lead.
• Coordinate study meetings, agendas, presentations, minutes, training materials, and investigator meetings.
• Collate feasibility and site-selection data, including site usability database reviews.
• Facilitate document reviews and maintain version-controlled regulatory, pharmacy, and laboratory manuals.
• Track site activation, enrolment, monitoring visits, registry postings, and scheduled compliance reports.
• Reconcile the Trial Master File and track close-out documents, product reconciliation, and CRA visits.
• Maintain SharePoint sites, site contacts, BDRM line listings, and third-party vendor oversight.
• You proactively identify issues, elevate delays, and recommend departmental process improvements.

This role requires:

• Bachelor's degree or five years of relevant experience.
• At least two years of industry-related experience.
• An advanced related degree with one to two years of relevant experience is preferred.

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.