BeOne Medicines Germany GmbH
Clinical Research Associate(m/w/x)
VollzeitRemoteBerufserfahren
Hamburg, Bremen, Berlin
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BEBeOne Medicines Germany GmbH
Senior Clinical Research Associate(m/w/x)
Hamburg, Bremen, Berlin
VollzeitRemoteSenior
Nejo KI-Zusammenfassung
Clinical monitoring and site selection for oncology trials, advancing patient access to therapies. 3-5 years clinical monitoring experience in oncology trials required. Work focused on public policy and patient therapy access.
Anforderungen
- BS in scientific or healthcare discipline preferred
- At least 3-5 years monitoring experience
- Experience in oncology/onco-hematology global trials preferred
- Advanced knowledge of clinical research regulations
- 3-5 years CRA monitoring experience
- Experience in oncology/onco-hematology trials preferred
- Excellent communication and interpersonal skills
- Ability to maintain effective stakeholder relationships
- Excellent organizational and problem-solving skills
- Effective time management skills
- Good command of English and German
- Efficiency in Microsoft Office and hardware
Aufgaben
- Execute clinical monitoring per ICH and GCP guidelines
- Perform site selection and evaluation activities
- Manage oncology trial initiation and conduct
- Collaborate with regional study teams on timelines
- Identify gaps and propose corrective actions
- Provide local expertise for study start-up
- Complete therapeutic and protocol-specific training
- Deliver protocol training to assigned sites
- Conduct onsite and remote monitoring visits
- Document site findings and generate follow-up letters
- Track regulatory submissions and recruitment progress
- Manage CRF completion and data query resolution
- Maintain Trial Master Files and Investigator Site Files
- Ensure inspection readiness for studies and sites
- Report site progress to Clinical Operations
- Facilitate site audits and compliance visits
- Evaluate the integrity of site practices
- Escalate quality and GCP issues to investigators
- Mentor and buddy junior clinical research staff
- Act as escalation point for site-related concerns
- Review visit reports and identify significant risks
- Serve as subject matter expert for clinical operations
Berufserfahrung
- 3 - 5 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
Tools & Technologien
- Good Clinical Practice (GCP)
- International Conference on Harmonization (ICH) guidelines
- Microsoft Word
- Excel
- PowerPoint
- Outlook
- Laptop computer
- iPhone
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
Senior Clinical Research Associate(m/w/x)
Hamburg, Bremen, Berlin
VollzeitRemoteSenior
Nejo KI-Zusammenfassung
Clinical monitoring and site selection for oncology trials, advancing patient access to therapies. 3-5 years clinical monitoring experience in oncology trials required. Work focused on public policy and patient therapy access.
Anforderungen
- BS in scientific or healthcare discipline preferred
- At least 3-5 years monitoring experience
- Experience in oncology/onco-hematology global trials preferred
- Advanced knowledge of clinical research regulations
- 3-5 years CRA monitoring experience
- Experience in oncology/onco-hematology trials preferred
- Excellent communication and interpersonal skills
- Ability to maintain effective stakeholder relationships
- Excellent organizational and problem-solving skills
- Effective time management skills
- Good command of English and German
- Efficiency in Microsoft Office and hardware
Aufgaben
- Execute clinical monitoring per ICH and GCP guidelines
- Perform site selection and evaluation activities
- Manage oncology trial initiation and conduct
- Collaborate with regional study teams on timelines
- Identify gaps and propose corrective actions
- Provide local expertise for study start-up
- Complete therapeutic and protocol-specific training
- Deliver protocol training to assigned sites
- Conduct onsite and remote monitoring visits
- Document site findings and generate follow-up letters
- Track regulatory submissions and recruitment progress
- Manage CRF completion and data query resolution
- Maintain Trial Master Files and Investigator Site Files
- Ensure inspection readiness for studies and sites
- Report site progress to Clinical Operations
- Facilitate site audits and compliance visits
- Evaluate the integrity of site practices
- Escalate quality and GCP issues to investigators
- Mentor and buddy junior clinical research staff
- Act as escalation point for site-related concerns
- Review visit reports and identify significant risks
- Serve as subject matter expert for clinical operations
Berufserfahrung
- 3 - 5 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
Tools & Technologien
- Good Clinical Practice (GCP)
- International Conference on Harmonization (ICH) guidelines
- Microsoft Word
- Excel
- PowerPoint
- Outlook
- Laptop computer
- iPhone
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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