Specialist, Clinical Trials

Overview

In this role you support the operational aspects of planning, start-up, conduct, and close-out of clinical studies, collaborating with Neurocrine, CROs, and investigator sites to ensure compliant, high-quality trial execution. You will help manage documentation, submissions, and study timelines, contributing to efficient trial delivery within a cross-functional team. This position offers exposure to global trials, regulatory standards, and ongoing process improvements in clinical operations. You will play a key part in maintaining data integrity and subject safety across studies.

Responsibilities

• Support FDA/ICH/GCP-compliant conduct of clinical studies with internal teams and CROs
• Prepare data and materials for study design discussions
• Provide administrative support for CRO invoicing, metrics tracking, and issue management
• Assist in study team meetings and monitor study issues; create study timelines
• Participate in recruitment activities and monitor essential documents
• Contribute to study start-up and on-site monitoring activities as needed
• Maintain organized eTMF, assist with QC and inspections readiness
• Develop and review consent documents; manage translations and distribution of letters to sites/IRBs
• Coordinate essential document collection and IRB/IEC submissions
• Support sponsor oversight and documentation in TMF plans and templates
• Foster collaboration across clinical operations to standardize processes
• Assist in translation and distribution of study materials to sites and CROs
• Ensure timely, accurate documentation updates and issue resolution

Key requirements

• BS/BA in Scientific field or equivalent and 2+ years in clinical trials or CRO/vendor management exposure; or MSc in Scientific field with some experience
• Knowledge of clinical drug development processes, ICH, GCP, FDA regulations, and EU directives
• Experience in clinical operations, from start-up through close-out, and some trial management knowledge
• Ability to plan activities and adapt to changing circumstances; time management skills
• Good communication, problem-solving, and analytical thinking
• Team player with a proactive, process-improvement mindset
• Strong computer skills and attention to detail
• Familiarity with eTMF processes and sponsor oversight is a plus

• strong communication
• problem-solving
• analytical thinking
• GCP and regulatory knowledge
• IRB/IEC submissions experience
• eTMF system familiarity

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