Clinical Study Manager (Clinical Affairs) – UNEEG medical A/S

About UNEEG medical A/S

UNEEG medical A/S is an entrepreneurial and ambitious company specializing in providing the epilepsy community with more accurate knowledge of seizures to support improvement in epilepsy care, ultimately aiming at improving patients’ quality of life. Our unique subcutaneous EEG solution for remote monitoring of brain activity was CE marked in 2019 and our continued international growth and technology roadmap ambitions will require several new functions and competencies in the years to come.

UNEEG medical A/S was founded in 2005. We currently employ approximately 100 people in Europe – the majority of these are situated in our new headquarters in Allerød, Denmark. Our employees represent various cultures, backgrounds, skills, and years of experience. Read more about us at www.uneeg.com.

The situation

The exciting journey is just beginning with establishing a new field in epilepsy with ground-breaking technology. Ultra-long-term EEG monitoring has so far not been an option for epilepsy patients and the potential for both management and research is being unfolded with the use of this new product solution for monitoring and analysing brain activity (EEG).

The product solution comprises of an active implant, an implantation tool, an external recorder that communicates with the implant, data infrastructure and EEG analysing software, where UNEEG medical is acting as either legal manufacturer or distributor of the products.

UNEEG medical is currently present in 6 European countries with some local sales offices in place. The product solution is used by leading centers in epilepsy (King’s College London (UK), Filadelfia (DK)). Further a clinical investigation (IDE) is progressing to support the market approval process in USA, which is expected to be finalized within the next 2-3 years.

UNEEG medical is looking for a Clinical Study Manager to lead the planning, setup, and execution of clinical investigation for our medical devices. This is a broad role where you are expected to develop a good knowledge of and hands-on experience with various classes of medical devices and all stages of clinical development.

Clinical Affairs

Reporting to the Head of Clinical Affairs, you will be joining a team of 5 highly dedicated colleagues with different backgrounds enjoying close cooperation with different stakeholders. The department involved in supporting our commercial organisation with projects throughout Europe as still more hospitals are working towards establishing a new practice for treating epilepsy. UNEEG medical is a scale-up and thus a smaller organisation. The Clinical Affairs department therefore covers a broad range of tasks such as supporting commercial with literature to back up product claims, establishing, and managing study sites in coordination with local staff, assisting in data management, performing statistical follow-up, supporting development projects, and keeping SOPs updated on new regulations and guidelines.

Your role

As a Clinical Study Manager, you will join our clinical team, where the key focus is on gathering clinical evidence to support the research and business objectives across the product life cycle. The position offers an extraordinary opportunity for the right candidate to join a company “on the move” and make a significant difference for both company and patients. Most studies and sites are in Europe, but you sometimes step in when help is needed with a study in the US or other regions. You must expect app. 40 days of travel activity per year.

In summary, your role will include:

  • Develop and maintain all study related documentation and secure ethics and competent authority approval
  • Liaise with the principal investigators and site staff to establish study sites and manage the study from start-up to close-out 
  • Monitor studies remotely and on site to ensure generations of high-quality data in compliance with applicable standards, local regulations, and study protocols
  • Assist in the building of databases, perform data cleaning, simple data analysis and write summary reports on clinical data to regulatory authorities, ethical committees, and Notified Bodies   
  • Support the clinical team e.g. providing input to clinical evaluation reports and post market surveillance plans for the project teams or execution of design validation activities.

Ideal candidate profile

As a candidate, you can come with experience with driving clinical investigations in the field, setting up a study from A to Z also involving perhaps a customer or end-user, as you will be working externally in this role. You are used to driving your tasks independently but also like a team effort where we are sometimes doing a task for the first time.

You are comfortable working with technical products including electronics, mechanics, and software. You thrive being a support to a commercial organisation as well as to customers.

You should also thrive in a start-up/scale up like culture – a friendly and learning environment, where you get to take ownership and develop your role as the company develops.

In summary, your background should include:

  • A Technical or scientific degree (MSc or PhD) in a health-related field, biology, medical, biomedical engineering or similar
  • Some years of experience with planning, execution, and monitoring of clinical investigation from a similar position
  • Knowledge of FDA regulations and their practical implementation will be an advantage
  • Both spoken and written English at a professional level
  • Excellent planning and organisational skills
  • Good communication skills and comfortable with presenting in front of an audience
  • Able to present complex information to clinical and non-clinical audiences, and maintain a good relationship with investigators and site staff
  • Able to thrive in a changing and learning environment where no two days are alike and unforeseen events may require your immediate attention.

Why you should join UNEEG medical A/S

An entrepreneurial, purpose driven and fast-growing international company with Danish headquarters with a flat and informal collaborating culture with a long-term strategic focus for helping a patient group in high need of solutions to improve quality of life.

Good career possibilities alongside the company’s expansion.

The role is based in Allerød, DK.

How to come into condsideration

Please contact: Partner at Peoplement, Anne Borgen, either by mail: anne@peoplement.dk or phone +45 61690101 for more information. We will be evaluating candidates continuously until we find the right match.

Apply here.