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Project Manager
vor 4 Wochen
Hamburg, Hamburg, Deutschland Marken VollzeitJob Summary:The Project Manager will be responsible for the overall planning, execution, monitoring, control, and closure of kit operation activities for clinical supply projects. This role requires strong project management and organizational skills, as well as the ability to communicate effectively with clients and manage multiple projects.Main...
Clinical Research Operations Manager
vor 3 Monaten
As a Clinical Trial Manager (f/m/x) at Sidekick Health Germany GmbH, you will be integral to our Research and Development team, tasked with validating the clinical efficacy of our innovative products.
Your responsibilities include meticulously planning, executing, and supervising clinical trials within the DiGA sector, ensuring compliance with established protocols, regulatory standards, and timelines while prioritizing patient safety and generating high-quality evidence for our digital therapeutic solutions.
Key Responsibilities- Trial Oversight: Direct and manage clinical trial operations for our medical devices, ensuring adherence to protocols, ethical standards, and regulatory requirements under strict timelines.
- Site Coordination: Identify and contract clinical trial sites, provide necessary training, and conduct regular monitoring visits.
- Data Oversight: Manage and analyze clinical trial data effectively.
- Documentation: Assist in the documentation processes for medical devices and DiGA in accordance with MDD and MDR, focusing on clinical evaluations, investigations, post-market surveillance, and risk management.
- Regulatory Compliance: Prepare and manage ethics submissions and develop essential documents, training materials, and manuals to ensure 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 experience in managing clinical research studies for medical devices, particularly in the DiGA landscape.
- Strong understanding of MDR, GDPR, GCP, and relevant safety and regulatory standards.
- Exceptional time management skills and meticulous attention to detail.
- Solid analytical abilities and foundational knowledge of research methodologies.
- Capable of working in an agile and adaptable manner.
- Positive demeanor with effective problem-solving skills.
- Enthusiastic and engaging team player.
- Dynamic Team: Become part of our international team of experts dedicated to transforming healthcare and enhancing patient care globally.
- Collaborative Environment: Our innovative approach fosters flat hierarchies, allowing you to work independently and take full ownership of your projects.
- Professional Growth: We prioritize your personal development through a feedback-oriented culture and tailored growth opportunities.
- Competitive Benefits: Enjoy a comprehensive compensation package, including MacBooks, ergonomic workstations, flexible hours, and remote work options.
- Relocation Assistance: We offer support for your relocation if you are moving from another country to join our team.
- Employee Wellness: We promote work-life balance and health through initiatives like subsidized fitness programs and contributions to public transport and pension schemes.
- Welcoming Atmosphere: Experience a supportive working environment in our office, complemented by various corporate benefits, sports activities, and team events.
Sidekick Health is a leader in digital health and therapeutics, committed to revolutionizing patient-centered care through innovative solutions. Founded by two physicians, we offer a wide array of digital health programs across various therapeutic areas, including oncology, cardiovascular diseases, metabolic disorders, and inflammatory diseases. With a strong presence in the DiGA market, we have already supported over 40,000 individuals in their weight loss journeys through our pioneering product, zanadio.
