Avomind
Senior Clinical Research Scientist - Digital Cardiology and Heart Failure(m/w/x)
Vollzeitnur vor OrtSenior
Berlin
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
AVAvomind
Clinical Trial Operations Manager - Digital Cardiology and Heart Failure(m/w/x)
Berlin
ab 50.000 - 80.000 / Jahr
VollzeitVor OrtSenior
AI/ML
Nejo KI-Zusammenfassung
Leading FDA clearance trial for remote cardiac patient monitoring platform. 5+ years medical device/digital health clinical research experience required. Company shares, Urban Sports Club access.
Anforderungen
- Bachelor’s degree or higher in Life Sciences, Medicine, Biomedical Engineering, or related field
- 5+ years of experience in clinical research with medical devices, diagnostics, or digital health technologies
- 2+ years of trial or project management experience, ideally within multicenter, international trials
- Strong knowledge of GCP, ISO 14155, and FDA/MDR regulations
- Proven experience managing CROs, budgets, and external vendors
- Excellent written and verbal communication in English
- Experience in cardiology or heart failure research
- Familiarity with AI-based software as a medical device (SaMD) and remote monitoring technologies
- Background in clinical operations for FDA submissions (De Novo or 510(k))
- Advanced degree (MSc, PhD, MD) preferred
- Strategic and independent execution in complex, regulated environments
- Creative and structured problem-solving and adaptability to fast-changing priorities
- Strong collaboration and stakeholder management across global sites and senior KOLs
- Deep commitment to patient safety, data integrity, and clinical impact
Aufgaben
- Lead clinical operations for the FDA clearance trial
- Ensure compliance with GCP, ISO 14155, and FDA expectations
- Plan and manage site selection and initiation
- Plan and manage site training
- Plan and manage enrollment
- Plan and manage monitoring
- Plan and manage data management
- Plan and manage site close-out
- Oversee CRO for deliverables
- Oversee CRO for budgets
- Oversee CRO for quality metrics
- Support protocol development
- Support regulatory submissions (De Novo/510(k))
- Manage multiple global trials in parallel
- Manage ongoing observational studies in Europe and US
- Manage ongoing validation studies in Europe and US
- Collaborate with medical teams
- Collaborate with AI/data teams
- Collaborate with product teams
- Align study design with scientific development
- Align study design with technical development
- Engage with principal investigators
- Engage with KOLs
- Foster academic partnerships with institutions
- Foster clinical partnerships with institutions
- Ensure audit readiness across all studies
- Manage risks proactively across all studies
- Monitor study progress
- Monitor study budgets
- Prepare executive reports
- Communicate risks to leadership
- Communicate mitigation strategies to leadership
- Contribute to scientific dissemination
- Prepare abstracts
- Prepare publications
- Prepare conference presentations
Berufserfahrung
- 5 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- GCP
- ISO 14155
- FDA
- MDR
- AI-based software as a medical device (SaMD)
- remote monitoring technologies
Benefits
Sonstige Vorteile
- 10-25% international and national travel
Attraktive Vergütung
- Company shares
Gesundheits- & Fitnessangebote
- Access to Urban Sports Club
Modernes Büro
- Beautiful office in Berlin Mitte
Snacks & Getränke
- High-end espresso machine
- Drinks
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Avomind erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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AVAvomind
Clinical Trial Operations Manager - Digital Cardiology and Heart Failure(m/w/x)
Berlin
ab 50.000 - 80.000 / Jahr
VollzeitVor OrtSenior
AI/ML
Nejo KI-Zusammenfassung
Leading FDA clearance trial for remote cardiac patient monitoring platform. 5+ years medical device/digital health clinical research experience required. Company shares, Urban Sports Club access.
Anforderungen
- Bachelor’s degree or higher in Life Sciences, Medicine, Biomedical Engineering, or related field
- 5+ years of experience in clinical research with medical devices, diagnostics, or digital health technologies
- 2+ years of trial or project management experience, ideally within multicenter, international trials
- Strong knowledge of GCP, ISO 14155, and FDA/MDR regulations
- Proven experience managing CROs, budgets, and external vendors
- Excellent written and verbal communication in English
- Experience in cardiology or heart failure research
- Familiarity with AI-based software as a medical device (SaMD) and remote monitoring technologies
- Background in clinical operations for FDA submissions (De Novo or 510(k))
- Advanced degree (MSc, PhD, MD) preferred
- Strategic and independent execution in complex, regulated environments
- Creative and structured problem-solving and adaptability to fast-changing priorities
- Strong collaboration and stakeholder management across global sites and senior KOLs
- Deep commitment to patient safety, data integrity, and clinical impact
Aufgaben
- Lead clinical operations for the FDA clearance trial
- Ensure compliance with GCP, ISO 14155, and FDA expectations
- Plan and manage site selection and initiation
- Plan and manage site training
- Plan and manage enrollment
- Plan and manage monitoring
- Plan and manage data management
- Plan and manage site close-out
- Oversee CRO for deliverables
- Oversee CRO for budgets
- Oversee CRO for quality metrics
- Support protocol development
- Support regulatory submissions (De Novo/510(k))
- Manage multiple global trials in parallel
- Manage ongoing observational studies in Europe and US
- Manage ongoing validation studies in Europe and US
- Collaborate with medical teams
- Collaborate with AI/data teams
- Collaborate with product teams
- Align study design with scientific development
- Align study design with technical development
- Engage with principal investigators
- Engage with KOLs
- Foster academic partnerships with institutions
- Foster clinical partnerships with institutions
- Ensure audit readiness across all studies
- Manage risks proactively across all studies
- Monitor study progress
- Monitor study budgets
- Prepare executive reports
- Communicate risks to leadership
- Communicate mitigation strategies to leadership
- Contribute to scientific dissemination
- Prepare abstracts
- Prepare publications
- Prepare conference presentations
Berufserfahrung
- 5 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- GCP
- ISO 14155
- FDA
- MDR
- AI-based software as a medical device (SaMD)
- remote monitoring technologies
Benefits
Sonstige Vorteile
- 10-25% international and national travel
Attraktive Vergütung
- Company shares
Gesundheits- & Fitnessangebote
- Access to Urban Sports Club
Modernes Büro
- Beautiful office in Berlin Mitte
Snacks & Getränke
- High-end espresso machine
- Drinks
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Avomind erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
Avomind
Branche
Healthcare
Beschreibung
Avomind is the largest network of orthodontic clinics in Europe, revolutionizing invisible orthodontics with digital processes and cutting-edge technology.
Noch nicht perfekt?
- Avomind
Senior Clinical Research Scientist - Digital Cardiology and Heart Failure(m/w/x)
Vollzeitnur vor OrtSeniorBerlin - Avomind
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Vollzeitnur vor OrtJuniorBerlin - Sonova AG
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Vollzeitnur vor OrtSeniorBerlin - Bristol Myers Squibb
Senior Medical Science Liaison - Cardiovascular(m/w/x)
Vollzeitnur vor OrtSeniorKiel, Rostock, Greifswald, Berlin - AVOW GmbH
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Vollzeitnur vor OrtManagementBerlin