Nucs AI
Medical Affairs Lead(m/w/x)
VollzeitRemoteBerufserfahren
Berlin
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NUNucs AI
Associate Director, Medical Programs(m/w/x)
Berlin
VollzeitRemoteSenior
AI/ML
Nejo KI-Zusammenfassung
Managing daily clinical validation studies and investigator-led research at an AI-driven cancer care firm. 5+ years in clinical operations or medical programs management required. Significant equity upside, high autonomy.
Anforderungen
- 5+ years experience in clinical operations, medical programs management, or clinical research coordination
- Strong clinical study management background (protocol execution, site coordination, data management, regulatory compliance)
- Experience managing multi-site clinical studies or investigator-led research programs
- Excellent organizational and project management skills
- Strong written communication skills
- Bachelor’s degree in life sciences, public health, clinical research, or related field
- Experience in medical imaging, radiology, nuclear medicine, or oncology clinical research
- Familiarity with AI/ML clinical validation or SaMD regulatory pathways
- ACRP or SOCRA certification, or equivalent clinical research credentials
- Experience with electronic data capture systems, clinical trial management systems, or imaging core lab workflows
- Master’s degree in clinical research, public health, or related discipline
- Experience at MedTech startup or early-stage clinical-AI company
Aufgaben
- Manage daily clinical validation studies.
- Manage daily investigator-led research.
- Manage daily data collection initiatives.
- Coordinate clinical study protocols with sites.
- Coordinate patient enrollment with sites.
- Coordinate data submission timelines with sites.
- Coordinate compliance requirements with sites.
- Maintain study trackers, timelines, and milestone dashboards.
- Proactively identify risks and dependencies.
- Oversee onboarding and training for multi-site studies.
- Manage ongoing communication for multi-site studies.
- Manage clinical data collection workflows.
- Ensure data integrity, completeness, and traceability.
- Coordinate data transfer for model training.
- Coordinate data de-identification for model training.
- Coordinate data integration for model training.
- Support development and maintenance of clinical data agreements.
- Support development and maintenance of IRB submissions.
- Support development and maintenance of ethical approvals.
- Track and resolve data quality issues across studies.
- Prepare and maintain clinical study protocols.
- Prepare and maintain informed consent forms.
- Prepare and maintain clinical study reports.
- Prepare and maintain site files.
- Support regulatory submissions with clinical evidence summaries.
- Support regulatory submissions with study narratives.
- Support regulatory submissions with data packages.
- Ensure clinical programs comply with regulatory requirements.
- Ensure clinical programs comply with GCP guidelines.
- Ensure clinical programs comply with internal QMS processes.
- Liaise with medical, product, engineering, and quality teams.
- Coordinate medical team input for product development.
- Coordinate medical team input for feature validation.
- Coordinate medical team input for clinical feedback.
- Support scientific communications with clinical data.
- Support abstracts and presentations with study results.
- Manage vendor relationships for clinical services.
Berufserfahrung
- 5 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- AI/ML
- SaMD
- electronic data capture systems
- clinical trial management systems
- imaging core lab workflows
Benefits
Sonstige Vorteile
- Meaningful equity
Startup-Atmosphäre
- Outsized influence
Flexibles Arbeiten
- Autonomy and flexibility
- Remote-first work
Attraktive Vergütung
- Equity upside
- Competitive equity package
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Nucs AI 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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NUNucs AI
Associate Director, Medical Programs(m/w/x)
Berlin
VollzeitRemoteSenior
AI/ML
Nejo KI-Zusammenfassung
Managing daily clinical validation studies and investigator-led research at an AI-driven cancer care firm. 5+ years in clinical operations or medical programs management required. Significant equity upside, high autonomy.
Anforderungen
- 5+ years experience in clinical operations, medical programs management, or clinical research coordination
- Strong clinical study management background (protocol execution, site coordination, data management, regulatory compliance)
- Experience managing multi-site clinical studies or investigator-led research programs
- Excellent organizational and project management skills
- Strong written communication skills
- Bachelor’s degree in life sciences, public health, clinical research, or related field
- Experience in medical imaging, radiology, nuclear medicine, or oncology clinical research
- Familiarity with AI/ML clinical validation or SaMD regulatory pathways
- ACRP or SOCRA certification, or equivalent clinical research credentials
- Experience with electronic data capture systems, clinical trial management systems, or imaging core lab workflows
- Master’s degree in clinical research, public health, or related discipline
- Experience at MedTech startup or early-stage clinical-AI company
Aufgaben
- Manage daily clinical validation studies.
- Manage daily investigator-led research.
- Manage daily data collection initiatives.
- Coordinate clinical study protocols with sites.
- Coordinate patient enrollment with sites.
- Coordinate data submission timelines with sites.
- Coordinate compliance requirements with sites.
- Maintain study trackers, timelines, and milestone dashboards.
- Proactively identify risks and dependencies.
- Oversee onboarding and training for multi-site studies.
- Manage ongoing communication for multi-site studies.
- Manage clinical data collection workflows.
- Ensure data integrity, completeness, and traceability.
- Coordinate data transfer for model training.
- Coordinate data de-identification for model training.
- Coordinate data integration for model training.
- Support development and maintenance of clinical data agreements.
- Support development and maintenance of IRB submissions.
- Support development and maintenance of ethical approvals.
- Track and resolve data quality issues across studies.
- Prepare and maintain clinical study protocols.
- Prepare and maintain informed consent forms.
- Prepare and maintain clinical study reports.
- Prepare and maintain site files.
- Support regulatory submissions with clinical evidence summaries.
- Support regulatory submissions with study narratives.
- Support regulatory submissions with data packages.
- Ensure clinical programs comply with regulatory requirements.
- Ensure clinical programs comply with GCP guidelines.
- Ensure clinical programs comply with internal QMS processes.
- Liaise with medical, product, engineering, and quality teams.
- Coordinate medical team input for product development.
- Coordinate medical team input for feature validation.
- Coordinate medical team input for clinical feedback.
- Support scientific communications with clinical data.
- Support abstracts and presentations with study results.
- Manage vendor relationships for clinical services.
Berufserfahrung
- 5 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- AI/ML
- SaMD
- electronic data capture systems
- clinical trial management systems
- imaging core lab workflows
Benefits
Sonstige Vorteile
- Meaningful equity
Startup-Atmosphäre
- Outsized influence
Flexibles Arbeiten
- Autonomy and flexibility
- Remote-first work
Attraktive Vergütung
- Equity upside
- Competitive equity package
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Nucs AI 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.
Über das Unternehmen
Nucs AI
Branche
Healthcare
Beschreibung
Nucs AI is an innovative MedTech startup, transforming the clinical management of prostate cancer through cutting-edge AI-powered software solutions.
Noch nicht perfekt?
- Nucs AI
Medical Affairs Lead(m/w/x)
VollzeitRemoteBerufserfahrenBerlin - Nucs AI
Senior Product Manager(m/w/x)
VollzeitRemoteSeniorBerlin - BeOne Medicines Germany GmbH
Senior Clinical Research Associate(m/w/x)
VollzeitRemoteSeniorHamburg, Bremen, Berlin - Takeda
Associate Director, Study Site Engagement(m/w/x)
Vollzeitmit HomeofficeSeniorBerlin - Nucs AI
Machine Learning Scientist(m/w/x)
VollzeitRemoteBerufserfahrenBerlin, München