UNEEG medical A/S is looking for an experienced Clinical Research Associate to join an innovative company bringing novel brain-wave monitoring products to market. You will be part of our clinical team where key focus is on carrying through clinical studies which aim to substantiate the claims of our products. In the position as Clinical Research Associate, you will be the first point of contact with investigators and their teams and play a key role in generating and overseeing documentation and records. You will have the chance to impact our clinical processes as well as your own daily tasks and responsibilities. The position is full-time and office-based with exciting travel opportunities.
UNEEG medical A/S employs approximately 80 people and we are facing an international market launch. Combined, this is an extraordinary opportunity for the right candidate to join a company “on the move” and make a difference.
Your key responsibilities will be to:
- Liaise with the principal investigators and site staff to establish study sites
- Develop and review clinical study related documentation
- Gain regulatory and ethical approval where required and keep trial master files up to date
- 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 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
- Collaborate closely with colleagues across the company, especially Research and Development to facilitate trouble shooting, complaint handling, and collection of high-quality data to further develop our devices.
To succeed in the job, you need to have:
- A master’s degree in Life Sciences or equivalent.
- At least 3 years of experience from a similar position preferably 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 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
- You to be a part of a first mover organisation within EEG monitoring, developing high-end biomedical products
- A small but fast expanding organisation within the T&W Medical Group (formerly known as Widex Group)
Please submit your application and CV as soon as possible, and no later than March 5th, 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 firstname.lastname@example.org.
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.