Clinical research manager

HIRANI; Belfast City District; Hybrid; GBP 65,000 - 95,000; Full time

Benefits offered by this job

Private Health Insurance

Job summary

Neurovalens is seeking an experienced Clinical Research Manager to lead the planning, execution and oversight of our clinical trials and regulatory submissions for medical devices. Based in Belfast, you will manage timelines, budgets and stakeholder communications, and collaborate with global investigators, CROs and internal teams.

The role requires a Life Science degree, at least five years in clinical research, strong regulatory knowledge, and excellent communication and organisation skills.

Qualifications

• Degree in Life Science or related field.
• At least five years of clinical research experience.
• Experience in statistical analysis of clinical trial data.
• Familiarity with QMS in regulatory environment.
• Regulatory knowledge of medical devices.
• Excellent written and verbal communication skills.
• Demonstrates prioritisation and teamwork.
• Excellent organisation skills and ability to meet deadlines.
• Proficient with Microsoft Word, Excel and PowerPoint.
• Potential for share options and private health insurance.

Responsibilities

• Lead the management and coordination of clinical trial sites.
• Develop and maintain relationships with investigators and study staff.
• Lead investigator meetings and other study-related meetings.
• Prepare and manage clinical binder content.
• Prepare ethics submissions.
• Ensure studies follow the protocol, SOPs and GCP.
• Establish clinical timelines and performance metrics.
• Arrange CDA/Budget and other trial setup agreements.
• Negotiate and manage contracts, budgets, and payments for CROs.
• Compile study KPI and performance metrics and deliver trial data.
• Perform statistical analysis of trial outcomes.
• Prepare materials for FDA submission and regulatory bodies.
• Maintain regulatory compliance and conduct background research.

Skills

Clinical research experience

Statistical analysis

Regulatory knowledge

Communication skills

Organization

Teamwork

MS Office

Education

Degree in Life Science

Job description

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.

Key responsibilities

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.

Required criteria

Degree in a Life Science or other subject with a substantially relevant component

At least five years of clinical research 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

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