Reports To: Director of Clinical Research

Position Overview

Neuromod Devices is a global medical technology company founded to establish bimodal neuromodulation as a new standard of care for tinnitus, a condition that affects 15% of the global adult population. The culmination of Neuromod’s research and development in this area for over a decade is the groundbreaking bimodal neuromodulation tinnitus treatment device, Lenire®.

Neuromod has clinically proven the safety, efficacy and patient tolerability of Lenire through three large-scale clinical trials involving 600+ tinnitus patients and real-world evidence. Lenire research has been published in prestigious peer-reviewed scientific journals.

Neuromod’s comprehensive and consistent body of clinical trial and real world evidence saw Lenire® become the first device of its kind to be awarded an FDA De Novo Grant for the treatment of tinnitus in the United States of America.

We are now seeking to expand our clinical research team to work on various elements of clinical research projects but to primarily assist on the initiation and execution of a variety of research projects. This role reports directly to the Director of Clinical Research to coordinate and manage tasks but will also work closely with the Scientific Communications Manager. You will work with our clinical research and clinical affairs teams to fully understand the patient journey, internal processes and data available in order to create the appropriate material for each research project. You should be comfortable with the full research project cycle from initiation to close-out, where you will be required to create clinical documentation required as part of ethics submissions and see through the completion of research projects in line with the required regulation of a region (ISO 14155, MDR, FDA etc.). You should also be familiar with the process for disemination of results from research projects through either peer-reviewed journal articles, trade journals or conference abstracts for example.

Position Responsibilities and Essential Functions

  • ● Develop or coordinate development and approval of study documentation such as the study protocol, ICF, study-specific guidelines, regulatory documents, monitoring, data management and statistical analysis plans and clinical study report, in accordance with internal SOPs and GCP requirements.
  • ● Define and drive study/project timelines and milestones.
  • ● Contribute to the development of regulatory documents, responses to Health Authority/Competent Authority and EC/IRB questions.
  • ● Conduct monitoring activities to ensure data quality.
  • ● Ensure study team members are timely informed, trained and updated on their role and responsibilities through-out the duration of the study.
  • ● Liaise and coordinate with external study vendors, where applicable, for certain research projects.
  • ● Ensure that the team are regularly updated on research project/study progress, challenges and risks through-out the duration of the projects.
  • ● Work cross-functionally, in particular with the clinical affairs team on MDR related documentation requiring input from the research team such as the Clinical Development Plan, PMCF Plan and Report.
  • ● Oversee database lock activities to ensure timely data availability and coordinate study close out as needed.
  • ● Contribute to and work with the Scientific Communications team to disseminate results from research projects in peer-reviewed and trade journals.

General

● Lead by example in complying with the policies, procedures, and work instructions of Neuromod Devices;

● Comply with the procedures for retention, protection, retrieval, transfer, and disposal of records.

● Contribute to team effort by accomplishing related results as needed.

● Thoroughly document all issues related to quality assurance, GCP, GDP, and ISO compliance.

Education, Qualifications and Experience:

Education:

A PhD or Master’s Degree in life science, psychology, medical science, or biomedical engineering or equivalent industry experience in research/medical writing roles.

Required:

  • ● 3+ years of research experience in the healthcare or medical device industries or in a post-doctoral position.
  • ● Broad & in-depth expertise in clinical operations and regulations.
  • ● Exceptional technical writing skills.
  • ● Experience in executing a wide range of clinical trial activities (from initiation to clinical study report)
  • ● Experience selecting and managing external service providers
  • ● Strong attention to detail and commitment to quality.
  • ● Demonstrated expertise in global clinical research & development and project management (including risk management and contingency planning)
  • ● A team player with excellent interpersonal and communications skills, with the ability to solve problems ad-hoc.
  • ● Great attention to detail.

Preferred:

  • ● Relevant experience in the tinnitus, audiology, pain or neuromodulation fields.
  • ● Good understanding of research design methodology.
  • ● Experience publishing in peer-review scientific journals and with the review process.
  • ● Self-motivation so you can work with limited supervision.
  • ● Experience in managing multiple content and studies at different stages. 

Physical Demands

Must be willing to travel internationally

For further information please contact Aoife McNally aoife.mcnally@neuromoddevices.com