Clinical Study Manager

Join Us in Catalyzing Brain Health Therapy with Real-World Data

At UNEEG Medical, we are on a clear mission: improve epilepsy care and ultimately enhance patients’ quality of life through objective, real-world EEG data. Our sub-scalp EEG solution enables remote monitoring of brain activity and is already making an impact across Europe and the US. We are entrepreneurial and ambitious, blending the agility of a small company with the high standards expected in medical device industry.

Your role and team:

We are looking for a clinical study manager, who will play a key role in executing our ongoing and future clinical studies.

Our product portfolio consists of implantable, wearable and communication devices, which are class III medical devices in EU. We are already commercially available in Europe, and we are advancing towards US market entry. As a clinical study manager you will support our existing products portfolio and future development activities with clinical and real world evidence .

You will be part of our Clinical & Market Development team that collaborates closely with colleagues across the organization and external consultants to achieve our common goals. In the team we are transparent about our challenges and step in to help others when needed. We continuously seek to improve our processes and personal knowledge.

Your main responsibilities will be:

Site Management

• Ensure compliance with CIP, ISO14155 GCP, and subject safety
• Conduct and document site visits (selection, initiation, monitoring, close-out)
• Remote and on-site monitoring for data quality and protocol adherence
• Manage essential documents, device accountability, and study supplies
• Track site progress: IRB approvals, recruitment, CRF completion, query resolution

Study Management

• Lead day-to-day operations from start-up to close-out
• Support site identification and feasibility
• Manage vendors (CROs, labs, etc.)
• Coordinate timelines, risk management, and operational delivery
• Contribute to protocol, IB, SAP, and other study documents
• Lead internal meetings and maintain cross-functional communication
• Track KPIs, enrolment, and study metrics
• Ensure audit/inspection readiness
• Support data analysis, publications, and dissemination of results

You will thrive in this role if you have:

• Foundational Experience: Bringing hands-on experience from a similar role, even if limited, especially in site management
• Attention to Detail: Showing a systematic and analytical approach to tasks, with the ability to manage documentation accurately
• A team-player mentality: Being proactive in seeking guidance, asking questions, and working closely with more experienced colleagues
• Adaptability: Being pragmatic, resilient, and ready to take on new challenges as priorities shift

Your background:

• Minimum a bachelor’s degree, preferably within life science, clinical or medical science or similar
• Minimum 3 years clinical study management and monitoring experience within MedTech, pharma or biotech
• Experience in medical devices is an advantage
• Knowledge of ISO14155, FDA and EU clinical study regulations
• Excellent communication, vendor management, and organizational skills

It will be an advantage if you have additional experience with:

• Software as medical device (SaMD)
• Neurology, epilepsy or the like
• Working with clinical studies in the EU and US

Who are you as a person:

• You have excellent planning skills; able to manage several tasks simultaneously
• You have a systematic and analytical approach
• You are pragmatic, and equally fond of working in the details and keeping the overview
• You are fluent in English, spoken and written
• You are a technological savvy
• You are able to travel up to 40 days per year, depending on study requirements

Applicants must be eligible to work in Denmark and possess a valid work and residence permit if applicable. We are unable to support work permit applications or sponsorships

What we offer:

• A tight-knit team with a collaborative spirit and high professional standards
• A workplace with great energy, social activities, and a culture of togetherness
• A role based in our modern HQ in Allerød with good facilities and easy access

At UNEEG, your ideas matter, your work makes a difference, and your colleagues have your back.

Who to contact:

For more details about the job, please contact Senior Director, Clinical & Market Development, Kristian Lykke Fick, at +45 53 39 80 18.

How to apply:

Please send your CV and application as soon as possible. All applications must be in English and are treated confidentially. We will screen and invite candidates for interviews on an ongoing basis.

About UNEEG Medical

UNEEG Medical pioneers ultra long-term subcutaneous EEG monitoring to help physicians optimize treatment for epilepsy patients. Our CE-marked UNEEG EpiSight solution provides objective insights into seizure burden, enabling more personalized care. We collaborate with leading institutions across Europe and the US to help patients regain control of their life. At UNEEG Medical, we are currently 40 dedicated people with diverse backgrounds. Our HQ is in Allerød with subsidiaries in UK, Germany, Austria and the US. Our core values Togetherness, Integrity, and Dedication guide our work as we catalyze brain health therapy with real-world data.

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