Sanofi-Aventis Deutschland GmbH
Clinical Operations Study Country Lead I(m/w/x)
Vollzeitmit HomeofficeSenior
Frankfurt am Main
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Dein persönlicher KI-Karriere-Agent
SASanofi-Aventis Deutschland GmbH
Clinical Operations Study Country Lead(m/w/x)
Frankfurt am Main
Vollzeitmit HomeofficeBerufserfahren
AI/ML
Data Science
Nejo KI-Zusammenfassung
Country-level operational lead for biopharma clinical studies, managing timelines and budgets. AI expertise and GCP certification required. 14-week paid family leave, childcare benefits.
Anforderungen
- AI expertise and data-driven thinking
- University degree in medicine, pharmacy, biology, biochemistry or related natural science
- Experience in clinical research, project management, or field monitor/site-coordinator
- Solid knowledge of clinical development process and relevant therapeutic/disease area(s); GCP certificate
- Strong project management skills
- Data analytic skills and use of digital tools, platforms and systems
- Problem-solving and risk-management skills in clinical study environment
- Change management skills
- Interpersonal skills with ability to create and foster trustful relationships
- Willingness to travel ~ 10-20%
- Fluent German and English
Aufgaben
- Own country-level operational lead for clinical studies
- Accountable for strategic planning of clinical trials
- Manage performance of assigned clinical trials
- Oversee study timelines at country level
- Manage study budget at country level
- Ensure study conduct per SOPs and guidelines
- Act as strategic hub at country level
- Connect internal and external stakeholders
- Accelerate trial execution
- Represent CSU in Core Study Team meetings
- Report to CSU Team Lead
- Partner with COSL on study matters
- Deliver study as planned at CSU level
- Consult or escalate operational issues
- Develop local study strategy
- Initiate recruitment strategies
- Initiate retention strategies
- Identify successful site mapping
- Set up site engagement plans
- Organize local kick-off meetings
- Lead set-up activities
- Manage local study performance
- Ensure compliance with timelines
- Drive performance with risk assessment
- Manage site engagement
- Support site staff
- Escalate issues as needed
- Collaborate on budget preparation
- Manage financial resources
- Address budget-related issues promptly
- Act as main link to local monitoring team
- Collaborate with Vendor Functional Line Managers
- Plan engagement activities
- Participate in engagement activities
- Coordinate local team meetings
- Establish collaboration with Medical Affairs
- Maintain data quality
- Ensure patient safety
- Ensure compliance with study metrics
- Ensure CRA training
- Collaborate on audit activities
- Ensure system readiness
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Deutsch – verhandlungssicher
- Englisch – verhandlungssicher
Tools & Technologien
- AI
- digital tools
- platforms
- systems
- GCP
Benefits
Gesundheits- & Fitnessangebote
- High-quality healthcare
Mentale Gesundheitsförderung
- Prevention programs
Sicherer Arbeitsplatz
- Long-term illness coverage
Großzügige Elternzeit
- 14-week paid family leave
Kinderbetreuung
- Childcare benefits
Modernes Büro
- Modern working environment
Flexibles Arbeiten
- Hybrid flexible working hours
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Sanofi-Aventis Deutschland GmbH 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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SASanofi-Aventis Deutschland GmbH
Clinical Operations Study Country Lead(m/w/x)
Frankfurt am Main
Vollzeitmit HomeofficeBerufserfahren
AI/ML
Data Science
Nejo KI-Zusammenfassung
Country-level operational lead for biopharma clinical studies, managing timelines and budgets. AI expertise and GCP certification required. 14-week paid family leave, childcare benefits.
Anforderungen
- AI expertise and data-driven thinking
- University degree in medicine, pharmacy, biology, biochemistry or related natural science
- Experience in clinical research, project management, or field monitor/site-coordinator
- Solid knowledge of clinical development process and relevant therapeutic/disease area(s); GCP certificate
- Strong project management skills
- Data analytic skills and use of digital tools, platforms and systems
- Problem-solving and risk-management skills in clinical study environment
- Change management skills
- Interpersonal skills with ability to create and foster trustful relationships
- Willingness to travel ~ 10-20%
- Fluent German and English
Aufgaben
- Own country-level operational lead for clinical studies
- Accountable for strategic planning of clinical trials
- Manage performance of assigned clinical trials
- Oversee study timelines at country level
- Manage study budget at country level
- Ensure study conduct per SOPs and guidelines
- Act as strategic hub at country level
- Connect internal and external stakeholders
- Accelerate trial execution
- Represent CSU in Core Study Team meetings
- Report to CSU Team Lead
- Partner with COSL on study matters
- Deliver study as planned at CSU level
- Consult or escalate operational issues
- Develop local study strategy
- Initiate recruitment strategies
- Initiate retention strategies
- Identify successful site mapping
- Set up site engagement plans
- Organize local kick-off meetings
- Lead set-up activities
- Manage local study performance
- Ensure compliance with timelines
- Drive performance with risk assessment
- Manage site engagement
- Support site staff
- Escalate issues as needed
- Collaborate on budget preparation
- Manage financial resources
- Address budget-related issues promptly
- Act as main link to local monitoring team
- Collaborate with Vendor Functional Line Managers
- Plan engagement activities
- Participate in engagement activities
- Coordinate local team meetings
- Establish collaboration with Medical Affairs
- Maintain data quality
- Ensure patient safety
- Ensure compliance with study metrics
- Ensure CRA training
- Collaborate on audit activities
- Ensure system readiness
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Deutsch – verhandlungssicher
- Englisch – verhandlungssicher
Tools & Technologien
- AI
- digital tools
- platforms
- systems
- GCP
Benefits
Gesundheits- & Fitnessangebote
- High-quality healthcare
Mentale Gesundheitsförderung
- Prevention programs
Sicherer Arbeitsplatz
- Long-term illness coverage
Großzügige Elternzeit
- 14-week paid family leave
Kinderbetreuung
- Childcare benefits
Modernes Büro
- Modern working environment
Flexibles Arbeiten
- Hybrid flexible working hours
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Sanofi-Aventis Deutschland GmbH 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
Sanofi-Aventis Deutschland GmbH
Branche
Pharmaceuticals
Beschreibung
Das Unternehmen bietet Arzneimittel zur Prävention von Herz-Kreislauf-Erkrankungen an und setzt sich für die Verbesserung der Lebensqualität ein.
Noch nicht perfekt?
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