Avomind
Senior Clinical Research Scientist - Digital Cardiology and Heart Failure(m/w/x)
Full-timeOn-siteSenior
Berlin
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AVAvomind
Clinical Trial Operations Manager - Digital Cardiology and Heart Failure(m/w/x)
Berlin
from 50,000 - 80,000 / year
Full-timeOn-siteSenior
AI/ML
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 5 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- GCP
- ISO 14155
- FDA
- MDR
- AI-based software as a medical device (SaMD)
- remote monitoring technologies
Benefits
Other Benefits
- 10-25% international and national travel
Competitive Pay
- Company shares
Healthcare & Fitness
- Access to Urban Sports Club
Modern Office
- Beautiful office in Berlin Mitte
Snacks & Drinks
- High-end espresso machine
- Drinks
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Avomind and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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AVAvomind
Clinical Trial Operations Manager - Digital Cardiology and Heart Failure(m/w/x)
Berlin
from 50,000 - 80,000 / year
Full-timeOn-siteSenior
AI/ML
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 5 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- GCP
- ISO 14155
- FDA
- MDR
- AI-based software as a medical device (SaMD)
- remote monitoring technologies
Benefits
Other Benefits
- 10-25% international and national travel
Competitive Pay
- Company shares
Healthcare & Fitness
- Access to Urban Sports Club
Modern Office
- Beautiful office in Berlin Mitte
Snacks & Drinks
- High-end espresso machine
- Drinks
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Avomind and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Avomind
Industry
Healthcare
Description
Avomind is the largest network of orthodontic clinics in Europe, revolutionizing invisible orthodontics with digital processes and cutting-edge technology.
Not a perfect match?
- Avomind
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