BeOne Medicines Germany GmbH
Senior Clinical Research Associate(m/w/x)
VollzeitRemoteSenior
Hamburg, Bremen, Berlin
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BEBeOne Medicines Germany GmbH
Clinical Research Associate(m/w/x)
Hamburg, Bremen, Berlin
VollzeitRemoteBerufserfahren
Nejo KI-Zusammenfassung
Overseeing oncology and hematology trials at a patient advocacy organization. Minimum 2 years monitoring experience required, oncology global trials experience preferred. Regular travel to trial sites.
Anforderungen
- BS in relevant scientific discipline
- Minimum 2 years monitoring experience
- Experience in oncology global trials preferred
- Understanding of clinical trial processes
- Knowledge of ICH and regulatory guidelines
- 2 years pharmaceutical/CRO monitoring experience
- Experience in oncology/hematology trials preferred
- Excellent communication and interpersonal skills
- Excellent organizational and multi-tasking skills
- Fluency in English and German
- Efficiency in Microsoft Office and Outlook
Aufgaben
- Execute clinical monitoring at trial sites
- Adhere to ICH guidelines and GCP standards
- Perform site selection and initiation activities
- Monitor oncology and hematology clinical trials
- Collaborate with the Regional Clinical Operations Manager
- Maintain study timelines and quality standards
- Identify gaps and propose corrective actions
- Support study start-up with local expertise
- Conduct site identification and feasibility assessments
- Provide protocol training to assigned sites
- Perform routine monitoring and closeout visits
- Complete detailed monitoring visit reports
- Track regulatory submissions and recruitment progress
- Manage CRF completion and data query resolution
- Maintain regular communication with clinical sites
- Ensure inspection readiness for all studies
- Facilitate site audits and oversight visits
- Escalate quality and GCP issues appropriately
- Attend disease-specific and general CRA training
Berufserfahrung
- 2 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
Tools & Technologien
- Microsoft Word
- Excel
- MS Project
- MS PowerPoint
- Outlook
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens BeOne Medicines Germany 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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BEBeOne Medicines Germany GmbH
Clinical Research Associate(m/w/x)
Hamburg, Bremen, Berlin
VollzeitRemoteBerufserfahren
Nejo KI-Zusammenfassung
Overseeing oncology and hematology trials at a patient advocacy organization. Minimum 2 years monitoring experience required, oncology global trials experience preferred. Regular travel to trial sites.
Anforderungen
- BS in relevant scientific discipline
- Minimum 2 years monitoring experience
- Experience in oncology global trials preferred
- Understanding of clinical trial processes
- Knowledge of ICH and regulatory guidelines
- 2 years pharmaceutical/CRO monitoring experience
- Experience in oncology/hematology trials preferred
- Excellent communication and interpersonal skills
- Excellent organizational and multi-tasking skills
- Fluency in English and German
- Efficiency in Microsoft Office and Outlook
Aufgaben
- Execute clinical monitoring at trial sites
- Adhere to ICH guidelines and GCP standards
- Perform site selection and initiation activities
- Monitor oncology and hematology clinical trials
- Collaborate with the Regional Clinical Operations Manager
- Maintain study timelines and quality standards
- Identify gaps and propose corrective actions
- Support study start-up with local expertise
- Conduct site identification and feasibility assessments
- Provide protocol training to assigned sites
- Perform routine monitoring and closeout visits
- Complete detailed monitoring visit reports
- Track regulatory submissions and recruitment progress
- Manage CRF completion and data query resolution
- Maintain regular communication with clinical sites
- Ensure inspection readiness for all studies
- Facilitate site audits and oversight visits
- Escalate quality and GCP issues appropriately
- Attend disease-specific and general CRA training
Berufserfahrung
- 2 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
Tools & Technologien
- Microsoft Word
- Excel
- MS Project
- MS PowerPoint
- Outlook
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens BeOne Medicines Germany 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
BeOne Medicines Germany GmbH
Branche
Pharmaceuticals
Beschreibung
The company is focused on advancing public policy objectives and advocating for patient access to therapies in the healthcare sector.
Noch nicht perfekt?
- BeOne Medicines Germany GmbH
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