PSI CRO
Senior / Clinical Research Associate(m/w/x)
Full-timeWith HomeofficeSenior
München
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AS
Astellas PharmaStudy Start-Up / Site Activation Specialist(m/w/x)
München
Full-timeWith Home OfficeSenior
Data Science
Description
As a site-facing expert, you will drive clinical study start-up activities by coordinating site activations and ensuring regulatory compliance to help reach program goals.
Let AI find the perfect jobs for you!
Upload your CV and Nejo AI will find matching job offers for you.
Requirements
- •Sehr gute Deutsch-, Englisch- und weitere Europäische Sprachkenntnisse
- •Erfahrung im Study Start-up in mehreren Ländern
- •Umfassende Erfahrung mit klinischen Studien
- •Verständnis lokaler SSU-Prozesse und -Anforderungen
- •Kenntnisse der Arzneimittelentwicklung und ICH-/GCP-Richtlinien
- •Nachgewiesene Projektmanagement-Fähigkeiten
- •Erfahrung in funktionsübergreifender Zusammenarbeit und Matrixstrukturen
- •Mitwirkung an Studien in frühen Entwicklungsphasen
- •Bachelor-Abschluss in Lebenswissenschaften oder vergleichbare Qualifikation
- •Proficiency in German, English and additional languages
- •Study Start-up experience in multiple countries
- •Extensive clinical trial experience and conduct
- •Good understanding of local SSU processes
- •Knowledge of drug development and ICH/GCP
- •Proven project management skills
- •Experience in cross-functional and matrix teams
- •Involvement in early development studies
- •BA/BS degree life science or equivalent
Education
Bachelor's degree
Work Experience
approx. 4 - 6 years
Tasks
- •Act as a local expert for study start-up activities
- •Manage and track assigned site activations
- •Utilize clinical systems like CTMS for data collection
- •Ensure compliance with GCP, ICH, and regulatory guidelines
- •Coordinate with study teams and internal stakeholders
- •Identify and escalate issues regarding SSU deliverables
- •Oversee site activities from initial listing to activation
- •Collect CDAs and site questionnaires
- •Negotiate Informed Consent Forms and manage escalations
- •Handle IRB, EC, and regulatory submissions
- •Prepare study document templates and IMP release packages
- •Update project status and financial data in tracking tools
- •Provide administrative support for clinical technologies
Tools & Technologies
ICH/GCP guidelines
Languages
German – Business Fluent
English – Business Fluent
Italian – Business Fluent
Spanish – Business Fluent
French – Business Fluent
Benefits
Flexible Working
- •Hybrid working model
- •Flexible working hours
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Astellas Pharma 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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AS
Astellas PharmaStudy Start-Up / Site Activation Specialist(m/w/x)
München
Full-timeWith Home OfficeSenior
Data Science
New Job?Nejo!
The AI Job Search Engine
Description
As a site-facing expert, you will drive clinical study start-up activities by coordinating site activations and ensuring regulatory compliance to help reach program goals.
Let AI find the perfect jobs for you!
Upload your CV and Nejo AI will find matching job offers for you.
Requirements
- •Sehr gute Deutsch-, Englisch- und weitere Europäische Sprachkenntnisse
- •Erfahrung im Study Start-up in mehreren Ländern
- •Umfassende Erfahrung mit klinischen Studien
- •Verständnis lokaler SSU-Prozesse und -Anforderungen
- •Kenntnisse der Arzneimittelentwicklung und ICH-/GCP-Richtlinien
- •Nachgewiesene Projektmanagement-Fähigkeiten
- •Erfahrung in funktionsübergreifender Zusammenarbeit und Matrixstrukturen
- •Mitwirkung an Studien in frühen Entwicklungsphasen
- •Bachelor-Abschluss in Lebenswissenschaften oder vergleichbare Qualifikation
- •Proficiency in German, English and additional languages
- •Study Start-up experience in multiple countries
- •Extensive clinical trial experience and conduct
- •Good understanding of local SSU processes
- •Knowledge of drug development and ICH/GCP
- •Proven project management skills
- •Experience in cross-functional and matrix teams
- •Involvement in early development studies
- •BA/BS degree life science or equivalent
Education
Bachelor's degree
Work Experience
approx. 4 - 6 years
Tasks
- •Act as a local expert for study start-up activities
- •Manage and track assigned site activations
- •Utilize clinical systems like CTMS for data collection
- •Ensure compliance with GCP, ICH, and regulatory guidelines
- •Coordinate with study teams and internal stakeholders
- •Identify and escalate issues regarding SSU deliverables
- •Oversee site activities from initial listing to activation
- •Collect CDAs and site questionnaires
- •Negotiate Informed Consent Forms and manage escalations
- •Handle IRB, EC, and regulatory submissions
- •Prepare study document templates and IMP release packages
- •Update project status and financial data in tracking tools
- •Provide administrative support for clinical technologies
Tools & Technologies
ICH/GCP guidelines
Languages
German – Business Fluent
English – Business Fluent
Italian – Business Fluent
Spanish – Business Fluent
French – Business Fluent
Benefits
Flexible Working
- •Hybrid working model
- •Flexible working hours
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Astellas Pharma 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
Astellas Pharma
Industry
Pharmaceuticals
Description
The company develops innovative medicines in immunology, oncology, and urology, focusing on patient-centric solutions.
Not a perfect match?
- PSI CRO
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