Clinical Evaluation Expert
vor 6 Monaten
Klenico Health AG is a HealthTech company in Zurich and Berlin, which has set itself the goal of helping people with mental stress or illness.
In cooperation with leading clinics in Europe, we have developed a web-based, CE-marked medical device software that guides healthcare professionals through the diagnostic process for mental disorders.
We are currently preparing for the MDR certification process and are looking for a Clinical Evaluation Expert to support the team and lead the clinical evaluation activities.
The main working location is Berlin or Zurich. Remote work is possible with the willingness to travel to the team every 2-3 weeks. A valid working permit for Switzerland or EU is required. In addition to full-time, part-time 60-90% would also be an option.
Tasks
As a Clinical Evaluation Expert, you will be responsible for leading the clinical evaluation process of our medical device software, ensuring compliance with the EU Medical Device Regulation (MDR) and overseeing all clinical research activities. Your expertise will guide the development, execution, and analysis of clinical data and activities, ensuring that our product meets rigorous clinical and regulatory standards.
- Responsible for the strategy and execution of the clinical evaluation for Klenico’s medical device.
- Further develop and implement comprehensive clinical evaluation plan to assess the safety and performance of the software.
- Analyze and interpret clinical data, prepare and manage the clinical evaluation report, and contribute to regulatory submissions.
- Lead the design and execution of clinical studies.
- Support the Post-Market Surveillance process and initiate and manage the Post-market Clinical Follow-up activities.
- Work closely with cross-functional teams, including R&D, product development, risk management, and regulatory affairs, to provide input for the product design and development processes.
- Manage relationships with external partners, including clinical investigators, CROs, and other stakeholders.
**Requirements**:
- Knowledge in clinical psychology and diagnostic procedures of mental disorders.
- Minimum of 5 years of experience in clinical evaluation and/or related scientific work, specifically with medical devices.
- Strong understanding of the clinical evaluation requirements under the Medical Device Regulation (MDR).
- Experience in leading or coordinating clinical studies is an advantage.
- Experience in medical writing.
- Fluent in English.
- At a minimum, very good command of German.
- Highly self-organized team player with strong interpersonal skills.
**Benefits**:
- A meaningful role in an innovative company that aims to solve a growing global problem and is already in use with many clinical customers
- Collaboration with a motivated and multidisciplinary team in Berlin and Zurich
- Modern office in a coworking hub in Berlin and Zurich
- Regular team events (outdoor activities, team lunches and aperitifs)
- Personal development opportunities
- Attractive remuneration
-
Pharmacovigilance Literature Expert
vor 2 Wochen
Berlin, Deutschland Allied Clinical Management GmbH VollzeitBe a part of a great team at one of the world's most recognized companies! Our client is a global pharmaceutical and chemical concern with over 100,000 employees worldwide and optimal working conditions. They would like to have a **Pharmacovigilance Literature Expert** come and join their PV Case Management Group in Berlin, Germany. Your employer will be...
-
Clinical Research Associate
vor 6 Monaten
Berlin, Deutschland ProPharma Group VollzeitFor the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners...
-
In-house Clinician
vor 6 Monaten
Berlin, Deutschland SGS VollzeitCompany Description We are SGS - the world’s leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 98,000 employees operate a network of 2,650 offices and laboratories, working together to enable a better, safer and more interconnected world. **Job Description**: As...
-
Snr Cra
vor 6 Monaten
Berlin, Deutschland Worldwide Clinical Trials Vollzeit**Requisition Number** **7086** **Employment Type***: **Contractor** **Who we are** We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with...
-
Contract Senior Clinical Research Associate
vor 7 Monaten
Berlin, Deutschland Ora Vollzeit**POSITION TITLE**: Senior Clinical Research Associate **DEPARTMENT**:Ora Europe **LOCATION**: Remote, Germany **Ora Values the Daily Practice of ** - Prioritizing Kindness - Operational Excellence - Cultivating Joy - Scientific Rigor_ At Ora, we are building the future of ophthalmic clinical research. As the world's leading full-service ophthalmic drug...
-
Clinician Rater-German Speaking
vor 5 Monaten
Berlin, Deutschland Worldwide Clinical Trials VollzeitRequisition Number8163Employment Type:Contractor – Not pushed to Sage Who we are We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with...
-
Medical Science Liaison
vor 8 Monaten
Berlin, Deutschland Syneos Health Clinical Vollzeit**Description** **You are a listener, an educator and a gifted cultivator of new and exciting opportunities grounded in science.** The Syneos Health Medical Science Liaison (MSL) will have primary responsibility for interacting with key stakeholders and healthcare providers. The MSL will collaborate with Physicians and other medical experts to support...
-
Freelance Clinical Research Associate
vor 2 Monaten
Berlin, Deutschland ClinChoice VollzeitClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture. We are looking for a dynamic person to join our in-house team as a Freelance Clinical Research Associate for 0.5 FTE. You will work on projects from our varied client base,...
-
Clinical Research Associate 2
vor 6 Monaten
Berlin, Deutschland Veranex, Inc. VollzeitVeranex is the only truly comprehensive, global, tech-enabled service provider dedicated to the medical technology industry. Offering expert guidance from concept-through-commercialization, including product design and engineering, preclinical and clinical development, data management, market access, regulatory affairs and quality assurance, Veranex enables...
-
Technical Product Manager
vor 4 Monaten
Berlin, Deutschland LGC Group VollzeitCompany Description LGC Clinical Diagnostics develops and manufactures a comprehensive portfolio of catalog and custom-developed diagnostic quality solutions and component materials for the extended life sciences industry. We partner with IVD assay developers, and pharmaceutical, CRO and academic institutions in commercialization activities across the...
-
Clinical & Regulatory Affairs Specialist
vor 6 Monaten
Berlin, Deutschland Meditrial Europe Ltd. Vollzeit**Company Overview**: Meditrial is a dynamic and rapidly growing multinational company specializing in providing clinical and regulatory services to medical device companies in the USA and Europe. With a commitment to excellence and innovation, we empower our clients to navigate complex regulatory landscapes and bring life-changing medical devices to market...
-
Early Clinical Lead
vor 3 Monaten
Berlin, Deutschland Bayer Vollzeit**At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our...
-
Apex Clinical Research Associate
vor 2 Monaten
Berlin, Deutschland Parexel VollzeitWe are now open for our next **APEX CRA Class - Start date November 25th 2024!** Are you a recent graduate and do you have 1 year or less of clinical experience? Did you study in the life sciences/data sciences/data analytics/clinical/nursing area? The Accelerated Program of Education, Exposure, and Experience for CRAs (APEX CRA) provides foundational...
-
Clinical Pharmacology Lead
vor 3 Monaten
Berlin, Deutschland Bayer Vollzeit**At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our...
-
Berlin, Deutschland Edwards Lifesciences VollzeitTranscatheter Heart Valve (THV) therapies – great-developed products of Edwards Lifesciences – supported by extensive customer training and service, our SAPIEN family of transcatheter aortic heart valves are the most widely prescribed transcatheter heart valves in the world. As a Regional Field Clinical Specialis t, you are a critical part of the...
-
Clinical Supply Chain Manager
vor 1 Woche
Berlin, Berlin, Deutschland Immutep VollzeitAbout the RoleImmutep, a leading biotechnology company developing immunotherapeutic products for cancer and autoimmune diseases, is seeking a highly skilled Clinical Supply Chain Manager to join its team. In this exciting role, you will play a crucial part in ensuring the timely and compliant supply of investigational products, comparators, and ancillary...
-
Clinical Research Liaison for Liver Diseases
vor 3 Wochen
Berlin, Berlin, Deutschland Gilead Sciences GmbH VollzeitKey ResponsibilitiesAs a Medical Scientist at Gilead Sciences GmbH, you will be responsible for all medical aspects of LVD to ensure future growth of this asset.Main Job Tasks:Proactive and reactive medical-scientific communication and education to physicians and other healthcare stakeholders in the field. This may include the organisation of local...
-
Wissenschaftlicher Mitarbeiter
vor 1 Monat
Berlin, Deutschland IQTIG - Institut für Qualitätssicherung und Transparenz im Gesundheitswesen VollzeitDas Institut für Qualitätssicherung und Transparenz im Gesundheitswesen - kurz IQTIG - ist das unabhängige wissenschaftliche Institut, das den Gemeinsamen Bundesausschuss (G-BA) dabei berät, wie er die medizinische Versorgungsqualität in Deutschland messen und verbessern kann. Als gemeinnützige Stiftung leistet das IQTIG einen wichtigen Beitrag zur...
-
Senior Auditor, Audits and Inspections Program
vor 1 Monat
Berlin, Deutschland Worldwide Clinical Trials Vollzeit**Who we are** We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. We are Worldwide Clinical Trials, and we are a...
-
Clinical Systems Application Specialist
vor 3 Wochen
Berlin, Berlin, Deutschland GULP – experts united VollzeitAt GULP – experts united, we are seeking a skilled Clinical Systems Application Specialist to join our team.The ideal candidate will have experience in supporting and customizing software solutions for the healthcare sector, with a focus on medical information systems. They will work closely with customers to advise them on the daily use of applications...