Associate Specialist, Clinical Trials

Neurocrine Biosciences; London; On-site; GBP 40,000 - 55,000; Full time

Job summary

A leading biopharmaceutical company in London seeks a Clinical Study Coordinator to support operational activities for clinical trials. The role involves managing trials, ensuring compliance with regulations, and collaborating with various stakeholders to facilitate smooth study execution. Ideal candidates will have a BS/BA degree and relevant experience in clinical operations.

Qualifications

• Relevant experience in clinical trials management.
• Knowledge of GCP, FDA regulations, and EU directives.

Responsibilities

• Assist study teams with all aspects of clinical trials.
• Prepare and distribute regulatory and study materials.
• Support eTMF management and quality control processes.

Skills

Teamwork

Communication

Organizational Skills

Education

BS/BA degree

Tools

CTMS

EDC

IWRS

Job description

Who We Are:

At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs.

What We Do:

Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids,* as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn,XandFacebook.

About the Role:

This role supports operational activities for planning, initiation, conduct, and closeout of assigned clinical studies (domestic and global). Key contributions include managing clinical trials using CROs and internal teams, overseeing essential document collection, IRB and IEC submissions, and ensuring compliance with GCP standards. The role involves collaboration with various stakeholders to facilitate smooth study execution and documentation.

Your Contributions (include, but are not limited to):

• Assist study teams with all aspects of clinical trials from start-up to closeout
• Create and maintain Study Status Documents
• Prepare and distribute regulatory and study materials
• Assist with safety reports and vendor invoices
• Establish collaborative relationships within the company and with external partners
• Help ensure studies comply with FDA, EU, ICH, and company SOPs
• Participate in study meetings, monitor study timelines, and support recruitment efforts
• Assist in study documentation, IRB submissions, and site communication
• Support eTMF management and quality control processes
• Additional duties as assigned

Requirements:

• BS/BA degree with relevant experience; CTMS/EDC/IWRS experience preferred
• Knowledge of clinical drug development, GCP, FDA regulations, and EU directives
• Understanding of clinical operations, protocols, and industry environment
• Basic regulatory knowledge and clinical terminology familiarity
• Strong teamwork, computer, communication, and organizational skills

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Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment, encouraging applications from diverse candidates even if their experience or qualifications do not exactly match the outlined requirements.