IQVIA
Clinical Research Associate II or Senior Clinical Research Associate I(m/w/x)
Full-timeWith HomeofficeSenior
Wien
from 4,200 / month
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AOAOP Health
Clinical Site Management Lead(m/w/x)
Wien
from 45,080 / year
Full-timeWith Home OfficeSenior
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 5 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- Office 365
- ICH-GCP
- standard clinical systems
Benefits
Flexible Working
- Flexible working hours
- Flexitime
- Home office
More Vacation Days
- Time-out days
Bonuses & Incentives
- Bonus scheme
- Bonus
Team Events
- Employee events
Mentorship & Coaching
- Structured onboarding
- Buddy system support
Modern Equipment
- Employee mobile phone
- Laptop
Learning & Development
- Initial and continuing education
Free or Subsidized Food
- Canteen
Parking & Commuter Benefits
- Good transport connection
- Parking spot
Company Vehicle
- Company car
Additional Allowances
- Meal allowance
Healthcare & Fitness
- Company doctor
- Health measures
Corporate Discounts
- Employee discount
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of AOP Health 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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Local Trial Manager - Sponsor Dedicated(m/w/x)
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AOAOP Health
Clinical Site Management Lead(m/w/x)
Wien
from 45,080 / year
Full-timeWith Home OfficeSenior
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 5 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- Office 365
- ICH-GCP
- standard clinical systems
Benefits
Flexible Working
- Flexible working hours
- Flexitime
- Home office
More Vacation Days
- Time-out days
Bonuses & Incentives
- Bonus scheme
- Bonus
Team Events
- Employee events
Mentorship & Coaching
- Structured onboarding
- Buddy system support
Modern Equipment
- Employee mobile phone
- Laptop
Learning & Development
- Initial and continuing education
Free or Subsidized Food
- Canteen
Parking & Commuter Benefits
- Good transport connection
- Parking spot
Company Vehicle
- Company car
Additional Allowances
- Meal allowance
Healthcare & Fitness
- Company doctor
- Health measures
Corporate Discounts
- Employee discount
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of AOP Health 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.
About the Company
AOP Health
Industry
Pharmaceuticals
Description
AOP Health is the European pioneer for integrated therapies for rare diseases and in critical care.
Not a perfect match?
- IQVIA
Clinical Research Associate II or Senior Clinical Research Associate I(m/w/x)
Full-timeWith HomeofficeSeniorWienfrom 4,200 / month - IQVIA Biotech
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Senior Clinical Research Associate(m/w/x)
Full-timeWith HomeofficeSeniorWien - IQVIA
Local Trial Manager - Sponsor Dedicated(m/w/x)
Full-timeRemoteSeniorWienfrom 70,100 / year - IQVIA
Clinical Research Associate I or II(m/w/x)
Full-timeWith HomeofficeJuniorWienfrom 3,600 / month