Clinical Research Supervisor
vor 4 Wochen
As a Clinical Trial Manager (f/m/x), you will be an integral part of our Research and Development team, responsible for validating the clinical efficacy of our innovative products.
Your primary responsibility will be to effectively plan, implement, and manage clinical trials within the DiGA sector, ensuring strict compliance with protocols, regulatory standards, and timelines while prioritizing patient safety and providing robust evidence for the effectiveness of our digital therapeutic solutions.
What You Can Anticipate from Us- Trial Oversight: Direct and manage clinical trial operations for our medical devices, ensuring adherence to protocols, ethical standards, and regulations within the defined timelines.
- Site Coordination: Identify and contract trial sites, deliver training, and conduct regular monitoring visits.
- Data Oversight: Oversee the management and analysis of trial data.
- Documentation: Assist in fulfilling documentation requirements for medical devices and DiGA in accordance with MDD and MDR regarding clinical evaluations, investigations, post-market surveillance, and risk management.
- Regulatory Compliance: Draft and manage ethics submissions and develop necessary documents, training materials, and manuals, ensuring compliance with DiGAV, GDPR, ISO 13485, ISO 14155, and GCP.
- Degree in a health or scientific discipline.
- Proficient in both written and spoken German and English.
- Significant professional experience in managing clinical research studies for medical devices, particularly in the DiGA sector.
- Thorough understanding of MDR, GDPR, GCP, and relevant safety and regulatory standards.
- Exceptional time management abilities and meticulous attention to detail.
- Strong analytical skills and foundational knowledge of research methodologies.
- Ability to work in an agile and adaptable manner.
- Positive mindset with effective problem-solving skills.
- Dynamic and enjoyable team member.
- Motivated Team: Join our international team of specialists dedicated to shaping the future of healthcare and enhancing patient care worldwide.
- Cross-Functional Collaboration: Our innovative approach with flat hierarchies allows you to work independently and take full responsibility for your projects, fostering efficient internal processes essential for the development of medical products.
- Personal Growth: We are committed to your continuous personal development through a feedback-oriented culture and tailored growth opportunities.
- Competitive Benefits: We offer attractive remuneration, provision of MacBooks, ergonomic workstations, flexible working hours, and options for remote work.
- Relocation Assistance: We provide support for your relocation if you are moving from another country to join our team.
- Employee Wellness: We promote a healthy work-life balance by subsidizing wellness programs and contributing to public transport and pension schemes.
- Supportive Environment: We prioritize your well-being in our office, offering a relaxed atmosphere with various corporate benefits, sports activities, and team events.
Sidekick Health is a leading innovator in digital health and therapeutics, dedicated to transforming patient-centered care through groundbreaking solutions. Founded by two physicians, we provide a wide array of digital health programs across various therapeutic areas, including oncology, cardiovascular diseases, metabolic disorders, and inflammatory conditions.
With a strong presence in the digital health applications market, Sidekick Health Germany has successfully assisted over 40,000 individuals in achieving weight loss through our first product, zanadio, a comprehensive digital obesity therapy.
Headquartered in Reykjavik and Hamburg, we employ a diverse team of over 250 professionals globally.
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