Clinical Research Manager

Neurovalens is seeking an experienced Clinical Research Manager to join our growing clinical team. This role will lead the planning, execution, and oversight of our clinical trials, while contributing to regulatory submissions for our medical devices. The successful candidate will manage timelines, budgets, and stakeholder communications, as well as working closely with the FDA and other regulatory authorities, global clinical investigators, and internal teams.

This position offers the opportunity to lead innovative clinical trials and play a critical role in advancing novel technologies from development through commercialisation.

Based in Belfast, Neurovalens is an innovative medical device company developing neuroscience‑driven technologies to deliver at‑home treatments for global health challenges in metabolic and mental health. Neurovalens has secured FDA approval for three medical devices and raised approximately £20 million in equity and debt funding. This is an exciting opportunity for an ambitious individual to join Neurovalens at a pivotal stage of its journey, as the company enters a period of rapid growth and scaling.

• Lead the management and coordination of clinical trial sites
• Develop and maintain good working relationships with investigators and study staff
• Lead and conduct investigator meetings and other study related meetings
• Prepare and manage clinical binder content
• Prepare ethic submissions
• Ensure studies are carried out according to the study protocol, standard operating procedures (SOPs), and Good Clinical Practice (GCP) regulations and study‑specific manuals and procedures.
• Establish clinical timelines and appropriate performance metrics for trial/site performance review
• Arrange Commercial Agreements for Trials (CDA/Budget etc.) in line with trial setup expectation
• Negotiate and manage the contracts, budgets, and payments for third‑party vendors, including CROs.
• Compile study KPI & Performance metrics
• Deliver clinical trial data from trials
• Statistical analysis of trial outcomes
• Preparation of material for FDA submission and other regulatory bodies
• Maintaining an understanding of and complying with regulatory requirements
• Carrying out background research and present findings
• Producing documents, briefing papers, reports, and presentations

This role requires a flexible working approach to meet the demands of the role. The position is based in Belfast and will require travel across the UK, Ireland, and internationally as needed.

• Degree in a Life Science or other subject with a substantially relevant component
• At least five years of clinical research experience
• Extensive project management experience
• Experience in statistical analysis of clinical trial data
• Familiarity with QMS in regulatory environment
• Ability to demonstrate regulatory knowledge of medical devices
• Excellent written and verbal communication skills
• Proven ability to prioritise
• Demonstrates the ability to work as part of a team
• Excellent organisation skills and proven ability to work to demanding deadlines
• Proficient in use of Microsoft products
  - Word, Excel, PowerPoint etc

• Potential for share options
• Private Health Insurance
• Flexible working

This vacancy is open only to applicants who already have the legal right to work in the United Kingdom. Neurovalens is not a licensed sponsor and is therefore not in a position to sponsor international applications or provide work visas. All offers of employment are subject to satisfactory evidence of the right to work in the UK.

Candidates who meet the required criteria and already have the legal right to work in the United Kingdom are invited to submit their CV.