ICON plc
Clinical Trial Manager(m/w/x)
Vollzeitmit HomeofficeBerufserfahren
Frankfurt am Main
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IQIQVIA RDS GmbH
Local Trial Manager(m/w/x)
Frankfurt am Main
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
Managing contracts and budgets for clinical trials at country level for a global CRO. 5+ years clinical research experience, 1-3 years local trial management, and Oncology expertise required. Direct country-level trial ownership.
Anforderungen
- Master’s or higher-level degree in life science
- Minimum of 5 years of clinical research experience in the pharmaceutical industry or CRO plus 1-3 years of local clinical trial management experience
- Therapeutic area expertise in Oncology
- Strong working knowledge of clinical research regulatory requirements, i.e., GCP and ICH guidelines
- Fluent language skills in German on at least C1 level and good command of English
- Strong IT skills in appropriate software and company systems
- Excellent decision-making and strong financial management skills
- Flexibility and ability to manage study teams in a virtual environment
- Willingness to travel occasionally for business meetings
Aufgaben
- Prepare high-level budget estimates for service requests
- Develop detailed budget proposals
- Manage contracts and review external service provider agreements
- Act as the primary contact for assigned trials at the country level
- Track project progress against planned timelines
- Monitor patient recruitment rates to meet enrollment targets
- Maintain and update trial management systems
- Analyze trial progress using management reports
- Participate in Health Authority inspections and internal audits
- Contribute to site-level recruitment strategies and contingency plans
- Manage vendor services and support vendor selection
- Review country-specific informed consent documents
- Ensure timely reporting of adverse events and serious adverse events
- Maintain accurate trial data and essential documents
- Collaborate with Global Trial Lead on quality issues
- Ensure accurate financial reporting and budget adherence
- Organize IEC/HA approvals to comply with local regulations
- Mentor or represent the functional area in process initiatives
Berufserfahrung
- 5 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Deutsch – verhandlungssicher
- Englisch – fortgeschritten
Tools & Technologien
- GCP
- ICH
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens IQVIA RDS 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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IQIQVIA RDS GmbH
Local Trial Manager(m/w/x)
Frankfurt am Main
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
Managing contracts and budgets for clinical trials at country level for a global CRO. 5+ years clinical research experience, 1-3 years local trial management, and Oncology expertise required. Direct country-level trial ownership.
Anforderungen
- Master’s or higher-level degree in life science
- Minimum of 5 years of clinical research experience in the pharmaceutical industry or CRO plus 1-3 years of local clinical trial management experience
- Therapeutic area expertise in Oncology
- Strong working knowledge of clinical research regulatory requirements, i.e., GCP and ICH guidelines
- Fluent language skills in German on at least C1 level and good command of English
- Strong IT skills in appropriate software and company systems
- Excellent decision-making and strong financial management skills
- Flexibility and ability to manage study teams in a virtual environment
- Willingness to travel occasionally for business meetings
Aufgaben
- Prepare high-level budget estimates for service requests
- Develop detailed budget proposals
- Manage contracts and review external service provider agreements
- Act as the primary contact for assigned trials at the country level
- Track project progress against planned timelines
- Monitor patient recruitment rates to meet enrollment targets
- Maintain and update trial management systems
- Analyze trial progress using management reports
- Participate in Health Authority inspections and internal audits
- Contribute to site-level recruitment strategies and contingency plans
- Manage vendor services and support vendor selection
- Review country-specific informed consent documents
- Ensure timely reporting of adverse events and serious adverse events
- Maintain accurate trial data and essential documents
- Collaborate with Global Trial Lead on quality issues
- Ensure accurate financial reporting and budget adherence
- Organize IEC/HA approvals to comply with local regulations
- Mentor or represent the functional area in process initiatives
Berufserfahrung
- 5 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Deutsch – verhandlungssicher
- Englisch – fortgeschritten
Tools & Technologien
- GCP
- ICH
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens IQVIA RDS 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.
Über das Unternehmen
IQVIA RDS GmbH
Branche
Healthcare
Beschreibung
IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries.
Noch nicht perfekt?
- ICON plc
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