BeOne Medicines Germany GmbH
Clinical Research Associate(m/w/x)
Vollzeit
Remote
Berufserfahren
Keine Angabe
Hamburg, Bremen, Berlin
BE
BeOne Medicines Germany GmbH5 Tage
Senior Clinical Research Associate(m/w/x)
Vollzeit
Remote
Senior
Keine Angabe
Hamburg, Bremen, Berlin
Nejo KI-Zusammenfassung
You will drive the success of oncology clinical trials by managing site performance and ensuring strict GCP compliance. Your role combines expert monitoring with mentoring junior staff to maintain high quality standards.
Lass KI die perfekten Jobs für dich finden!
Lade deinen CV hoch und die Nejo-KI findet passende Stellenangebote für dich.
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
Bachelor-Abschluss
Berufserfahrung
3–5 Jahre
Deine 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
Tools & Technologien
Good Clinical Practice (GCP)International Conference on Harmonization (ICH) guidelinesMicrosoft WordExcelPowerPointOutlookLaptop computeriPhone
Sprachen
Englisch – verhandlungssicher
Deutsch – verhandlungssicher
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.
Ähnliche Jobs direkt in deine Inbox?
Noch nicht perfekt?