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Clinical Site Management Lead(m/w/x)
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
- Englisch – verhandlungssicher
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
Noch nicht perfekt?
- IQVIAVollzeitmit HomeofficeSeniorWienab 4.200 / Monat
- IQVIA Biotech
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Clinical Site Management Lead(m/w/x)
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
- Englisch – verhandlungssicher
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
Über das Unternehmen
AOP Health
Branche
Pharmaceuticals
Beschreibung
AOP Health is the European pioneer for integrated therapies for rare diseases and in critical care.
Noch nicht perfekt?
- IQVIA
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