Neurovalens is seeking an ambitious clinical project manager to help the company deliver an exciting range of clinical trials and world-leading research projects. Our vision is to be the global leader in neuro-technology solutions, improving the lives of those who suffer from neurological issues. Based in Belfast, we pride ourselves on being one of the world's leading developers of new neurostimulation technologies.

We launched our first Modius product in August 2017 on the crowdfunding site Indiegogo with $2M of presales and have rapidly grown from a team of three in July 2017 to over 25.

Modius is a revolutionary neurostimulation device designed to help improve the lives of people who struggle with their weight by using neuro-technology to help make weight loss easier.

Reporting to the Chief Executive Officer this is an exciting time for an ambitious clinical research project manager to consider a career at Neurovalens, to lead on delivering clinical data across a range of studies with world-class research institutes globally. Over and above traditional project management of clinical trials this exciting role will include helping the business scale its research into conditions from diabetes, insomnia, anxiety, epilepsy through to pain relief. These are all necessary as we seek to move into a phase of rapid growth and significant scaling of the business. The company, its Board and Investors have ambitious plans to scale the business globally with a revenue target of $1BN in 5 years.

This role would suit either an individual with project management and clinical research experience gained perhaps in a Clinical Research Organisation (“CRO”), medical or pharma services businesses, or indeed in a medical device company. This exciting role will extend into assisting the business plan all its future research and development activities and will involve occasional travel to study sites and regulatory body offices abroad.

Key responsibilities and role requirements will include:

- Lead the project management of all clinical research activity undertaken by the company.

- Develop and maintain good working relationships with investigators and study staff.

- Ensure studies are carried out according to the study protocol, standard operating procedures (“SOPs”), and International Conference of Harmonisation /Good Clinical Practice (“GCP”) regulations and study-specific manuals and procedures.

- Prepare ethics submissions.

- Have an awareness of clinical study design.

- Prepare and manage clinical binder content.

- Assist with establishing and tracking clinical timelines and appropriate performance metrics.

- Review key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determine any appropriate action in conjunction with the study team (autonomy may vary with experience).

- Investigate queries, monitor discrepancies as applicable.

- Manage/oversee investigational product (“IP”) accountability and reconciliation process.

- Responsible for review or approval of IP release packages.

- Negotiate and manage the contracts, budgets, and payments for third-party vendors, including CROs.

- Work closely with our accountants to accurately track spend and monitor cash flow forecast for clinical plan delivery.

- Have an awareness of 21 Code of Federal Regulation part 11 requirements.

- Trained GCP and ISO 14155 conduct

- Be familiar with CE marking and 510k submission requirements in relation to clinical documentation and requirements

You will also help us run our clinical organisation in an efficient and effective way by;

- Carrying out background research and present findings.

- Producing documents, briefing papers, reports, and presentations.

- Write, or contribute to, preparation of clinical protocols, assessments, amendments, informed consent forms, study guides, case report forms, and any other clinical research related documents.

- Perform initial review of CRO and other third-party study vendor invoices to ensure that work is performed in accordance with the scope of work.

- Assist with Clinical Research Associate and third-party vendor training on protocols and practices.

- Assist in the identification and hiring of appropriate CROs and third party study vendors.

- Provide study-specific outsourcing specifications for Request for Proposals.

- Oversee or perform feasibility assessment for new clinical protocols.

- Identify, recruit and approve clinical investigators ensuring that study requirements can be met by these potential investigators/centres.

- Prepare and/or approve the design, format, and content of Case Report Forms, study procedure manuals and, subject instructions.

To be considered for this role you will have:

- Clinical Research Experience

- Extensive project management experience

- Working knowledge of ISO13485 is preferable but not essential as on the job training will be provided

- A proven track record of meeting client requirements

Skills:

- Clinical Research Experience,

- Extensive project management experience;

- Budget Management

Benefits:

- Share Options

- Pension

- Private Health Insurance