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AOAOP Health

Clinical Site Management Lead(m/w/x)

Wien
ab 45.080 / Jahr
Vollzeitmit HomeofficeSenior

Site management for rare disease and critical care clinical trials, coordinating regulatory submissions and co-monitoring. Life Sciences Bachelor's degree and 5 years CRA or 2 years Senior CRA experience required. Time-out days and bonus scheme.

Anforderungen

  • Bachelor's degree or higher in Life Sciences, Pharmacy, Medical Sciences, or related field
  • Minimum 5 years CRA experience or 2 years Senior CRA experience
  • Strong knowledge of clinical trial conduct, regulatory requirements, ICH-GCP
  • Experience with submissions to Competent Authorities and Ethics Committees
  • Experience with risk-based monitoring
  • Willingness to travel (max. 30%)
  • Fluent English (written/spoken), strong communication/presentation skills
  • Strategic planning, task prioritization, multi-project management ability
  • Proficiency in Office 365 and standard clinical systems
  • Bachelor's degree or higher in Life Sciences, Pharmacy, Medical Sciences, or related field
  • Minimum 5 years CRA experience or 2 years Senior CRA experience
  • Strong knowledge of clinical trial conduct, regulatory requirements, ICH-GCP
  • Experience with submissions to Competent Authorities and Ethics Committees
  • Experience with risk-based monitoring
  • Willingness to travel (max. 30%)
  • Fluent English (written/spoken), strong communication/presentation skills
  • Strategic planning, task prioritization, multi-project management ability
  • Proficiency in Office 365 and standard clinical systems

Aufgaben

  • Manage clinical studies from start-up to close-out
  • Prepare and coordinate submissions to Competent Authorities and Ethics Committees
  • Conduct co-monitoring visits to ensure patient safety, data integrity, and regulatory compliance
  • Build relationships with CRO personnel, site staff, and internal teams
  • Support and oversee CROs and freelance CRAs
  • Review and analyze study data for accuracy and completeness
  • Ensure availability of essential site documents for the TMF
  • Ensure quality of essential site documents for the TMF
  • Forecast IMP supply
  • Oversee drug accountability
  • Train CROs and study staff on protocols and procedures
  • Support creation of study core documents
  • Support preparation of study core documents
  • Support maintenance of study core documents
  • Assist with site selection
  • Assist with contracting procedures
  • Oversee and perform operational study activities for smooth trial execution

Berufserfahrung

  • 5 Jahre

Ausbildung

  • Bachelor-Abschluss

Sprachen

  • Englischverhandlungssicher

Tools & Technologien

  • Office 365
  • ICH-GCP
  • standard clinical systems

Benefits

Flexibles Arbeiten

  • Flexible working hours
  • Flexitime
  • Home office

Mehr Urlaubstage

  • Time-out days

Boni & Prämien

  • Bonus scheme
  • Bonus

Team Events & Ausflüge

  • Employee events

Mentoring & Coaching

  • Structured onboarding
  • Buddy system support

Moderne Technikausstattung

  • Employee mobile phone
  • Laptop

Weiterbildungsangebote

  • Initial and continuing education

Gratis oder Vergünstigte Mahlzeiten

  • Canteen

Parkplatz & Pendelvorteile

  • Good transport connection
  • Parking spot

Firmenwagen

  • Company car

Sonstige Zulagen

  • Meal allowance

Gesundheits- & Fitnessangebote

  • Company doctor
  • Health measures

Mitarbeiterrabatte

  • Employee discount
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens AOP Health 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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