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- Tasks: Lead and manage clinical trials, ensuring compliance and effective communication with stakeholders.
- Company: Join Neurovalens, a pioneering medical device company transforming health with neuroscience-driven technologies.
- Benefits: Competitive salary, private health insurance, potential for share options, and flexible working.
- Why this job: Make a real impact in advancing innovative health technologies while growing your career.
- Qualifications: Degree in Life Science, 5+ years of clinical research experience, and strong communication skills.
- Other info: Exciting opportunity to be part of a rapidly growing company with global reach.
The predicted salary is between 36000 - 60000 £ per year.
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
Clinical Research Manager in Belfast employer: HIRANI
Contact Detail:
HIRANI Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Clinical Research Manager in Belfast
✨Network Like a Pro
Get out there and connect with people in the clinical research field! Attend industry events, join relevant online forums, and don’t be shy about reaching out to professionals on LinkedIn. Building relationships can open doors to opportunities that aren’t even advertised.
✨Show Off Your Skills
When you get the chance to chat with potential employers, make sure to highlight your experience in managing clinical trials and your familiarity with regulatory requirements. Use specific examples from your past work to demonstrate how you’ve successfully navigated challenges in clinical research.
✨Prepare for Interviews
Before any interview, do your homework on the company and its products. Be ready to discuss how your background aligns with their goals, especially in terms of advancing innovative medical devices. Practise common interview questions and prepare some thoughtful questions to ask them too!
✨Apply Through Our Website
Don’t forget to apply directly through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re genuinely interested in being part of our team at Neurovalens.
We think you need these skills to ace Clinical Research Manager in Belfast
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Clinical Research Manager role. Highlight your relevant experience in clinical trials, regulatory submissions, and any specific achievements that align with what we’re looking for at Neurovalens.
Craft a Compelling Cover Letter: Your cover letter should tell us why you’re the perfect fit for this position. Share your passion for clinical research and how your skills can contribute to our innovative projects. Don’t forget to mention your familiarity with FDA regulations!
Showcase Your Communication Skills: Since this role involves a lot of stakeholder communication, make sure your written application reflects your excellent communication skills. Use clear and concise language, and don’t shy away from showing your personality!
Apply Through Our Website: We encourage you to apply through our website for a smoother process. It’s the best way for us to receive your application and ensures you don’t miss out on any important updates from our team.
How to prepare for a job interview at HIRANI
✨Know Your Clinical Research Inside Out
Make sure you brush up on your clinical research knowledge, especially around Good Clinical Practice (GCP) and regulatory requirements. Be ready to discuss your past experiences managing clinical trials and how you've navigated challenges in the field.
✨Showcase Your Communication Skills
As a Clinical Research Manager, you'll need to communicate effectively with various stakeholders. Prepare examples of how you've successfully managed relationships with investigators, study staff, and regulatory bodies. Highlight your ability to lead meetings and present findings clearly.
✨Demonstrate Your Organisational Skills
This role requires excellent organisation, so come prepared with examples of how you've managed timelines, budgets, and performance metrics in previous roles. Discuss any tools or methods you use to keep everything on track, especially when juggling multiple trials.
✨Be Ready for Problem-Solving Questions
Expect questions that assess your problem-solving abilities, particularly in high-pressure situations. Think of specific instances where you've had to adapt quickly or resolve conflicts during a trial. This will show your potential employer that you're capable of handling the demands of the role.
