BP13 Alexion Pharma Germany Company
Country Study Manager(m/w/x)
Vollzeitnur vor OrtBerufserfahren
München
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
ALAlexion
Clinical Research Associate(m/w/x)
München
VollzeitVor OrtManagement
Nejo KI-Zusammenfassung
Site identification, monitoring, and closeout visits for pharmaceutical trials. 1 year monitoring experience required. Work across diverse therapeutic areas.
Anforderungen
- Minimum 1 year CRA monitoring experience
- Bachelor’s degree in life science preferred
- Excellent knowledge of ICH-GCP guidelines
- Excellent knowledge of local regulations
- Good medical knowledge of Alexion Therapeutic Areas
- Good understanding of drug development process
- Excellent understanding of Clinical Study Management
- Excellent attention to details
- Excellent written and verbal communication skills
- Excellent collaboration and interpersonal skills
- Good negotiation skills
- Flexibility in schedule and willingness to travel
- Valid driving license
- Solid knowledge of clinical development processes
- Ability to work in remote collaboration
- Ability to manage matrix reporting structure
- Positive approach to managing change
- Champion efficient methods for clinical trials
- Ability to prioritize and manage multiple tasks
- Proactivity in communicating with stakeholders
- Ability to understand technology impact on projects
- Team oriented and flexible
- Experience in all study phases preferred
Aufgaben
- Perform site identification, selection, and initiation activities.
- Monitor site data and conduct closeout visits.
- Drive site performance and resolve study-related issues.
- Train and support Investigators and site staff.
- Develop recruitment plans and manage enrollment.
- Document recruitment barriers and implement solutions.
- Ensure monitoring KPIs are met and within quality ranges.
- Prepare and finalize monitoring visit reports in CTMS.
- Collect and upload essential documents to the eTMF.
- Participate in study start-up and regulatory maintenance.
- Assist with investigator nomination and feasibility activities.
- Collaborate with Medical Affairs and internal stakeholders.
- Escalate quality issues and compliance breaches as needed.
- Prepare for audits and regulatory inspections.
Berufserfahrung
- 1 Jahr
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Alexion 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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ALAlexion
Clinical Research Associate(m/w/x)
München
VollzeitVor OrtManagement
Nejo KI-Zusammenfassung
Site identification, monitoring, and closeout visits for pharmaceutical trials. 1 year monitoring experience required. Work across diverse therapeutic areas.
Anforderungen
- Minimum 1 year CRA monitoring experience
- Bachelor’s degree in life science preferred
- Excellent knowledge of ICH-GCP guidelines
- Excellent knowledge of local regulations
- Good medical knowledge of Alexion Therapeutic Areas
- Good understanding of drug development process
- Excellent understanding of Clinical Study Management
- Excellent attention to details
- Excellent written and verbal communication skills
- Excellent collaboration and interpersonal skills
- Good negotiation skills
- Flexibility in schedule and willingness to travel
- Valid driving license
- Solid knowledge of clinical development processes
- Ability to work in remote collaboration
- Ability to manage matrix reporting structure
- Positive approach to managing change
- Champion efficient methods for clinical trials
- Ability to prioritize and manage multiple tasks
- Proactivity in communicating with stakeholders
- Ability to understand technology impact on projects
- Team oriented and flexible
- Experience in all study phases preferred
Aufgaben
- Perform site identification, selection, and initiation activities.
- Monitor site data and conduct closeout visits.
- Drive site performance and resolve study-related issues.
- Train and support Investigators and site staff.
- Develop recruitment plans and manage enrollment.
- Document recruitment barriers and implement solutions.
- Ensure monitoring KPIs are met and within quality ranges.
- Prepare and finalize monitoring visit reports in CTMS.
- Collect and upload essential documents to the eTMF.
- Participate in study start-up and regulatory maintenance.
- Assist with investigator nomination and feasibility activities.
- Collaborate with Medical Affairs and internal stakeholders.
- Escalate quality issues and compliance breaches as needed.
- Prepare for audits and regulatory inspections.
Berufserfahrung
- 1 Jahr
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Alexion 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.
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
Alexion
Branche
Pharmaceuticals
Beschreibung
Alexion develops and sells life-changing drugs for rare and severe diseases, including neuroscience, aiming for excellent treatment outcomes.
Noch nicht perfekt?
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