I’m Lydia Eibye, a professional with a unique blend of expertise in law and healthcare. My background provides a comprehensive understanding of both regulatory and practical aspects of clinical trials and patient care. From a young age, I developed strong leadership skills, a sense of service, and responsibility. My early training in people relations laid the foundation for continuous learning and development. The skills and experience gained from my pro bono work ensure a compassionate and informed approach to all my professional endeavors.
My Commitment
With adaptability, innovation, and a strategic mindset, I excel in clinical governance and building effective stakeholder relationships. I continually engage in professional development to stay current with global trends, ensuring exceptional client service. My commitment to personal growth and Individual Social Responsibility though pro bono public health services, give a meaningful impact in underserved communities.
Professional Background
2023 – Present
Clinical Research Coordinator – Science 37
Scope: Regulatory compliance, safety and monitoring, quality management.
2023 – Present
Advisory Board Member – University of Copenhagen
Scope: Mental health. Conducting desk reviews and participating in group discussions with panel members.
2021 – 2022
CEO advisor – Start-up Company (Software as a Medical Device, SaMD)
Scope: MDR 2017/745 compliance, ISO 13485 standards, and associated regulations.
2018 – 2021
Mobile Research Nurse
Scope: Patient safety, clinical monitoring, and reporting.
2012 – 2020
Clinical Experience
Critical Care Nurse: Specializing in COPD and other respiratory diseases.
Liaison Nurse: Focus on mental health, social care, disease prevention, and health promotion.
Regulatory Compliance Proficiency:
- MDR 2017/745: Expert in navigating the complexities of the Medical Device Regulation, enabling me to provide valuable contributions to cross-functional teams and ensure regulatory compliance.
- Software as a Medical Device (SaMD): In-depth knowledge of ISO 13485 and related standards, allowing me to play a key role in guiding teams through compliance challenges while enhancing collaboration and operational efficiency.
Medical and Somatic Care Expertise
Extensive experience in the management of complex conditions, with a specialization in Pulmonary Diseases and a focus on:
- Neurodegenerative Diseases
- Infectious and Respiratory Diseases
- Dermatology
- Geriatrics
- Psychiatry
- Alcohol and Substance Use Disorder
- Alcohol and Drug Abuse Rehabilitation
- Palliative Care
This comprehensive background provides the insight necessary to address complex challenges in clinical trials and regulatory compliance.
Educational Background
- Greenwich University: Faculty of Biomedical Sciences
- University College Copenhagen
- Emilie Woolf College: ACCA
- Makerere University: Faculty of Law
- Law Development Centre
These qualifications provide a comprehensive understanding of both legal and healthcare aspects, ensuring a well-rounded foundation of expertise.
Connect with a Trusted Professional:
If you’re seeking a dedicated, knowledgeable, and strategic partner for your organization, I would be delighted to connect and explore how I can contribute to your success. Let’s achieve exceptional results together.
