Clinical Expert
hace 4 semanas
As a key member of the clinical team at SGS, you will play a crucial role in ensuring the safety and efficacy of in-vitro diagnostic medical devices available in Europe. Your expertise will be instrumental in ensuring that IVD devices sold in the EU provide relevant clinical benefits, minimize risks to patients, and reflect the state of the art in clinical diagnostics.
You will work closely with a team of clinicians and specialized product reviewers to assess the conformity of IVD devices in accordance with the EU In-Vitro Diagnostic Medical Devices Regulation 2017/746. Your clinical knowledge will be essential in providing oversight and ensuring that our assessment of the clinical aspects of IVD devices complies with the requirements of the IVDR.
Key Responsibilities:
- Act as the primary clinical expertise within SGS In-Vitro Diagnostic Medical Device certification activities
- Review and scientifically challenge the clinical data contained within the clinical performance evaluation, and any associated clinical investigations
- Coordinate the involvement of external clinical experts in the assessment process – deciding when external expertise is required, guiding the experts in their tasks, and evaluating the results
- Draw up records and reports regarding clinical assessment, and make recommendations to the notified body's decision makers
- Develop, update, and maintain appropriate training packages (with a focus on clinical evaluation assessments) for clinical experts and other team members
- Provide clinical input into client queries and meetings
Requirements:
- Professional experience in the field of clinical diagnostics, including experience as a physician, clinical pathologist, clinical scientist, clinical biochemist, biomedical scientist, clinical diagnostics laboratory manager, etc.
- University degree in a relevant domain
- At least two years of experience relevant to the generation and/or interpretation of performance data for in-vitro diagnostic assays in a clinical setting
- Fluent in English, reading and writing
Desirable:
- Knowledge of the EU In-Vitro Medical Device Regulation (IVDR) and related MDCG guidance
- Working experience in the IVD industry and knowledge of device clinical performance evaluation, such as verification and validation studies, clinical studies
- Experience with clinical investigations of in-vitro diagnostic assays or biomarker discovery studies
- A keen interest in medical device regulatory affairs
-
Clinical Trials Specialist
hace 1 semana
Madrid, Madrid, España Icon Clinical A tiempo completoKey ResponsibilitiesAs a Clinical Trials Specialist at Icon Clinical, you will serve as the primary point of contact for clients regarding digital measures and digital health technologies. Your key responsibilities will include:Building and maintaining strong, long-term relationships with clients to ensure their needs and expectations are met.Conducting...
-
Clinical Research Specialist
hace 2 semanas
Madrid, Madrid, España Icon Clinical A tiempo completoJob Title: Clinical Research SpecialistWe are seeking a highly skilled Clinical Research Specialist to join our team at Icon Clinical. As a key member of our team, you will be responsible for leading strategic initiatives and managing client relationships in the field of digital health.Key Responsibilities:Client Engagement and Relationship Management: Serve...
-
Clinical Research Specialist
hace 2 semanas
Madrid, Madrid, España Icon Clinical A tiempo completoJob Title: Clinical Research SpecialistWe are seeking a highly skilled Clinical Research Specialist to join our team at Icon Clinical. As a key member of our team, you will be responsible for leading strategic initiatives and managing client relationships in the field of digital health.Key Responsibilities:Client Engagement and Relationship Management: Serve...
-
Senior Clinical Research Associate
hace 1 semana
Madrid, Madrid, España Worldwide Clinical Trials, Llc A tiempo completoJob Title: Senior Clinical Research AssociateAt Worldwide Clinical Trials, we are seeking a highly skilled Senior Clinical Research Associate to join our team. As a key member of our clinical operations team, you will be responsible for ensuring the successful execution of our clinical research programs.Key Responsibilities:Conduct site qualifications,...
-
Clinical Research Specialist
hace 4 días
Madrid, Madrid, España Icon Clinical A tiempo completoKey Responsibilities:As a Clinical Research Specialist at ICON plc, you will be responsible for leading strategic calls and meetings with clients to discuss how to best apply digital measures and DHTs to all therapeutic areas covered in the client's portfolio. You will provide expert guidance on best practices, potential challenges, and solutions for...
-
Clinical Research Associate
hace 4 días
Madrid, Madrid, España Boston Scientific Gruppe A tiempo completoAbout the RoleThe Clinical Research Associate - Regulatory Expert supports the Global Clinical Operations Centre of Excellence, conducting activities consistent with GCO's mission of building a world-class shared clinical technology, process innovation, and clinical operations team, in partnership with the company's divisions, through technology enablement,...
-
Senior Clinical Research Associate
hace 6 días
Madrid, Madrid, España Worldwide Clinical Trials A tiempo completoCompany Overview:Worldwide Clinical Trials is a leading global contract research organization (CRO) that partners with biotechnology and pharmaceutical companies to create customized solutions that advance new medications.Our Mission:We are united in cause with our customers to improve the lives of patients through new and innovative therapies.Job Summary:We...
-
Clinical Expert
hace 4 semanas
Madrid, Madrid, España SGS A tiempo completoJob Title: In-House Clinician, Global Medical DevicesAs a key member of the clinical team at SGS, you will play a crucial role in ensuring the safety and efficacy of in-vitro diagnostic medical devices available in Europe. Your primary responsibility will be to act as the primary clinical expertise within SGS In-vitro Diagnostic Medical Device certification...
-
Clinical Expert
hace 4 semanas
Madrid, Madrid, España SGS A tiempo completoJob Title: In-House Clinician, Global Medical DevicesAs a key member of the clinical team at SGS, you will play a crucial role in ensuring the safety and efficacy of in-vitro diagnostic medical devices available in Europe. Your primary responsibility will be to act as the primary clinical expertise within SGS In-vitro Diagnostic Medical Device certification...
-
Clinical Expert
hace 2 semanas
Madrid, Madrid, España Sgs A tiempo completoJob DescriptionAs a key member of the clinical team at SGS, you will play a crucial role in ensuring the safety and efficacy of in-vitro diagnostic medical devices available in Europe.You will be responsible for acting as a key decision maker in ensuring that IVD devices sold in the EU provide relevant clinical benefits, minimize risks to patients, and...
-
Clinical Expert
hace 2 semanas
Madrid, Madrid, España Sgs A tiempo completoJob DescriptionAs a key member of the clinical team at SGS, you will play a crucial role in ensuring the safety and efficacy of in-vitro diagnostic medical devices available in Europe.You will be responsible for acting as a key decision maker in ensuring that IVD devices sold in the EU provide relevant clinical benefits, minimize risks to patients, and...
-
Ecoa Solutions Expert
hace 1 semana
Madrid, Madrid, España Icon Clinical Plc A tiempo completoAs a key member of the eCOA Solutions team, the eCOA Application Specialist plays a crucial role in ensuring the successful deployment of eCOA systems.Key responsibilities include:Reviewing and approving eCOA vendor design documentation to ensure alignment with the protocolCreating test plans and scripts to ensure system adequacyExecuting test scripts and...
-
Clinical Specialist
hace 1 semana
Madrid, Madrid, España Boston Scientific A tiempo completoAbout the RoleThe Electrophysiology Field Clinical Specialist will provide expert clinical product and technical assistance and training to physicians, Lab Staff, and sales representatives on the effective and safe use of the Farapulse system during case procedures within an assigned geography.Your ResponsibilitiesServes as primary resource for clinical...
-
Senior Medical Writer
hace 4 días
Madrid, Madrid, España Syneos - Clinical And Corporate - Prod A tiempo completoJob SummaryAs a Senior Medical Writer at Syneos Health, you will play a critical role in the development of clinical study protocols and reports. You will lead a team of medical writers and be responsible for managing medical writing activities associated with individual studies. Your expertise in regulatory compliance and medical writing will ensure that...
-
Clinical Specialist
hace 4 días
Madrid, Madrid, España Boston Scientific Gruppe A tiempo completoAbout the RoleThe Electrophysiology Field Clinical Specialist will provide expert clinical product and technical assistance and training to physicians, Lab Staff, and sales representatives on the effective and safe use of the Farapulse system during case procedures within an assigned geography, and in a manner that leads to meeting and exceeding business...
-
Clinical Program Manager
hace 5 días
Madrid, Madrid, España Idoven A tiempo completoAbout IdovenWe are a leading healthtech company using AI to prevent heart disease. Our mission is to save millions of lives by developing innovative cardiology solutions.About the RoleWe are seeking a highly skilled Clinical Program Manager to join our team. As a Clinical Program Manager, you will be responsible for the design, management, and execution of...
-
Clinical Specialist
hace 1 semana
Madrid, Madrid, España Boston Scientific Gruppe A tiempo completoJob SummaryAs a Field Clinical Specialist in Electrophysiology, you will provide expert clinical product and technical assistance to physicians, lab staff, and sales representatives on the effective and safe use of the Farapulse system. You will work closely with internal teams to develop and implement training programs, and provide ongoing support to ensure...
-
Clinical Expert for In-Vitro Diagnostic Medical Devices
hace 1 semana
Madrid, Madrid, España SGS A tiempo completoJob Title: Clinical Expert for In-Vitro Diagnostic Medical DevicesAs a Clinical Expert for In-Vitro Diagnostic Medical Devices, you will play a key role in ensuring the safety and efficacy of in-vitro diagnostic medical devices available in Europe. You will act as a key decision maker in ensuring that IVD devices sold in the EU provide relevant clinical...
-
Clinical Diagnostic Expert
hace 4 días
Madrid, Madrid, España Sgs A tiempo completoAt SGS, we are seeking a highly skilled Clinical Diagnostic Expert to join our rapidly growing team of regulatory professionals. This role will play a crucial part in helping the European healthcare ecosystem navigate the challenging transition to the new European In Vitro Diagnostics Regulation.The successful candidate will be responsible for assessing...
-
Digital Health Consultant
hace 1 semana
Madrid, Madrid, España Mygwork A tiempo completoJob Title: Digital Health Consultant - Clinical Software ExpertJob Summary:We are seeking a highly skilled Digital Health Consultant with expertise in clinical software to join our team. As a Digital Health Consultant, you will be responsible for deploying and supporting digital health solutions in the region, providing clinical software consultancy, and...