UNEEG medical is an innovative company which develops, manufactures and sells medical devices, and we have recently launched our first product solution for monitoring and analysing brain activity (EEG) for the epilepsy market.
We are looking for a Clinical Scientific Manager to join to our clinical team, where key focus is on gathering clinical data that aim to support the research and business objectives across the product life cycle. In the Clinical Scientific Manager position, you will have the opportunity to make a true difference as you will have the chance to impact our product development and clinical processes as well as your own daily tasks and responsibilities. The position is full-time and office-based with exciting travel opportunities.
Your key responsibilities will be to:
- Collaborate with the project teams in setting the direction for development of new products in compliance with the new medical device regulation
- Take responsibility for the clinical aspects of development projects including clinical evaluation plans, design validation, literature reviews, clinical evaluation reports, and post market surveillance plans to support our claiming strategies
- Develop and review clinical study related documentation and liaise with the principal investigators and site staff to establish study sites
- Train and guide site staff on protocol requirements, proper source documentation and case report form completion
- Monitor clinical studies remotely and on site to ensure generations of high-quality data in compliance with the protocol, company SOPs, ISO14155, and applicable local and legal requirements
- Perform data analysis, prepare manuscripts for publication and/or reports on clinical data to regulatory authorities, ethical committees and Notified Bodies, as required
- Maintain, develop and improve our protocols, processes and structures for clinical evaluation, clinical investigations, data management and post market surveillance
You must expect app. 30 days of travel activity per year.
To succeed in the job, you need to have:
- A master’s degree in Life Sciences or equivalent.
- 5 years of experience from a similar position preferable within the medical device field
- Knowledge of FDA regulations and their practical implementation will be an advantage
- You speak Danish and English fluently and master written English at a professional level
- You thrive in writing larger scientific reports and deep dive into the literature
- You have excellent planning and organisational skills
- You are team-oriented but also an independent worker with strong problem-solving capabilities
- You have good communication skills, can present complex information to both clinical and non-clinical disciplines, and maintain a good relationship with investigators and site staff
- A stimulating and challenging work environment bringing innovative products to market
- A dynamic workplace with skilled colleagues who emphasise having fun and creating a pleasant work atmosphere
- A job with significant opportunities to influence the company’s success and make a difference for the clinicians and chronic patients
Please submit your application and CV as soon as possible, and no later than April 18th, 2021. We will screen and invite candidates for interviews on an ongoing basis.
If you have any questions regarding the position or company, you are welcome to contact Head of Clinical affairs Lykke Blaabjerg, telephone no. +45 41 41 42 44 or by email email@example.com.
About UNEEG medical A/S
UNEEG medical A/S was founded in 2005 and is owned by T&W Medical A/S, former Widex Group. UNEEG medical A/S is an entrepreneurial and ambitious company, pioneering cognitive technologies that collect, monitor and analyse brain activity (EEG). The devices can be used for medical and diagnostic purposes within epilepsy and detect and alert diabetics of severe hypoglycaemia, hence aiming at improving patients’ quality of life. UNEEG medical A/S employs approximately 80 people and is facing an international market launch which requires a number of new functions and competencies. The office is located in Lynge but within the next 6 months we will relocate to a site nearby. Read more at www.uneeg.com.