Clinical Study Manager

Are you experienced in planning and implementing clinical investigations and contributing to research projects?

As Clinical Study Manager at UNEEG medical, you will join the Clinical Operation, where the key focus is on gathering clinical evidence to support the research and business objectives across the product life cycle. You will lead the planning, setup, and execution of clinical investigations for UNEEGs medical devices, as well as be responsible for data generation activities and interaction with investigational sites, clinical consultants, and CROs. You will monitor and oversee current clinical investigations, ensuring smooth and compliant studies.

Your key responsibilities are:

• 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
• Collaborate with CROs and take responsibility for sponsor oversight
• Write summary reports on clinical data to competent authorities, ethical committees, and Notified Bodies
• Support the clinical development team, e.g., providing input to clinical evaluation reports and post-market surveillance plans for the project teams or execution of design validation activities

Your qualifications are:

• Minimum 3 years of experience in planning, executing, and monitoring clinical investigations from a similar position, preferably within the medical device field
• Knowledge of EU/MDCG and FDA regulations, and experience with practical implementation in standard processes
• Used to managing clinical investigation documentation
• Experience with competent authority and ethical committee interactions
• Experience with selection and managing CROs

You have a BSc, MSc, or Ph.D. degree in a health-related field such as pharmacology, biology, medicine, biomedical, engineering, or similar. Practical experience from the industry is most desired.

You are a person with excellent planning and organizational skills and experience from clinical operations. You are a great communicator and a natural networker who manages to build and maintain good relationships with internal and external personnel. Furthermore, you manage to motivate and engage all people you come across during your work. You are good at keeping an overview, and you know when to intervene and when to make space for others. As a colleague, you are able to spread joy and get people on board through an involving and passionate approach.

UNEEG medical offers a position allowing you to grow with an organization poised for growth in an entrepreneurial and social work environment. At UNEEG, you will be able to lead the strategies and procedures of the clinical investigations throughout the entire life cycle. You will be part of an exciting and unique journey, accelerating the improvement of patients suffering from epilepsy.

Traveling: Up to 20 days a year.

Domicile: The UNEEG office in Allerød.

For more details about the job or the company, please contact Associate Director, Clinical Operations, Pia Nordmand, at +45 2070 9801. All applications must be in English and are treated confidentially.

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 and is today owned by the families behind the large hearing aid company Widex/WS Audiology. We currently employ approximately 120 people in Europe – the majority of these are situated in our headquarters in Allerød, Denmark. Our employees represent various cultures, backgrounds, skills, and years of experience.

Field
Clinical Operations

Job requirements

• Minimum 3 years of experience in planning, executing, and monitoring clinical investigations from a similar position, preferably within the medical device field
• Knowledge of EU/MDCG and FDA regulations, and experience with practical implementation in standard processes
• Used to managing clinical investigation documentation
• Experience with competent authority and ethical committee interactions
• Experience with selection and managing CROs
• You have a BSc, MSc, or Ph.D. degree in a health-related field

Place of work
Borupvang
3450 Allerød

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Contact
Steen Hesthaven HR partner

Pia Nordmand Manager

Published at
3/1/2024

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