Clinical Study 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 compliance with established 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 strict adherence to protocols, ethical standards, and regulatory requirements under tight deadlines.
- Site Coordination: Identify and contract trial sites, deliver training, and conduct regular site assessments.
- Data Oversight: Supervise the management and analysis of trial data.
- Documentation: Assist in fulfilling documentation obligations for medical devices and DiGA in accordance with MDD and MDR concerning clinical evaluations, investigations, post-market surveillance, and risk management.
- Regulatory Compliance: Draft and manage ethics submissions and develop necessary documents, training resources, 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 pertinent 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 demeanor with effective problem-solving skills.
- Enthusiastic and engaging personality.
- Dynamic Team: Join our international team of specialists dedicated to shaping the future of healthcare and enhancing patient care globally.
- Collaborative Environment: Our innovative work culture with flat hierarchies empowers you to work independently and take full ownership of your responsibilities.
- Professional Growth: We foster a feedback-oriented culture focused on individual development opportunities to support your continuous personal growth.
- Competitive Benefits: We offer attractive remuneration, MacBooks, ergonomic workstations, flexible working hours, and unlimited remote work options.
- Relocation Assistance: We provide support for those relocating from other countries to join our team.
- Employee Wellness: We promote work-life balance and health through subsidies for fitness programs and transportation benefits.
- Welcoming Atmosphere: We prioritize your well-being in our office environment, offering corporate benefits, regular fitness activities, and team events.
Sidekick Health is a leading innovator in digital health and therapeutics, committed to transforming patient-centered care through groundbreaking solutions. Established by two physicians, our company offers a diverse 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 (DiGA), Sidekick Health has successfully assisted over 40,000 individuals in managing their weight through our first product, zanadio, a comprehensive digital obesity therapy.
Headquartered in Reykjavik and Hamburg, we employ over 250 professionals worldwide, dedicated to advancing the field of digital health.
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