BP13 Alexion Pharma Germany Company
Country Study Manager(m/w/x)
Vollzeitnur vor OrtBerufserfahren
München
Neuer Job?Nejo!
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ALAlexion Pharma Germany Company
Senior Clinical Study Administrator(m/w/x)
München
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Administering clinical study documentation, eTMF, and CTMS for drug development. 3 years drug development experience and process understanding required. Direct support for local study team.
Anforderungen
- Bachelor's Degree in a related discipline
- Proficiency with MS Office Suite
- Understanding of the drug development process
- Minimum experience of 3 years in Development
- Excellent collaboration and interpersonal skills
- Strong organizational skills
- Strong attention to detail
- Effective written and verbal communication skills
- Prior experience working in clinical research
- Medical knowledge and ability to learn relevant areas
- Ability to work in a remote environment
- Positive approach to change management
- Championing efficient methods for clinical trials
- Team oriented and flexible
- Understanding impact of technology on projects
Aufgaben
- Support the local study team in achieving quality and timely study deliverables
- Set up and maintain the electronic Trial Master File (eTMF)
- Track regulatory documents and team training documentation
- Manage milestones in the Clinical Trial Management System (CTMS)
- Assist with start-up activities, including CDA delivery and negotiation
- Distribute and collect documents during contract negotiation
- Prepare Site Files and obtain site activation approvals
- Collaborate with PMCO, CRAs, SSU manager, and study vendors
- Act as a central point of contact for project communications and documentation
- Contribute to the development and maintenance of project management tools
- Collaborate on global initiatives to standardize processes
- Assist with local language translations and submissions to IRB/CEC/CA
- Support local COM team with face-to-face study and team meetings
- Assist with team teleconferences and staff onboarding
Berufserfahrung
- 3 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- MS Office Suite
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Alexion Pharma Germany Company 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 Pharma Germany Company
Senior Clinical Study Administrator(m/w/x)
München
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Administering clinical study documentation, eTMF, and CTMS for drug development. 3 years drug development experience and process understanding required. Direct support for local study team.
Anforderungen
- Bachelor's Degree in a related discipline
- Proficiency with MS Office Suite
- Understanding of the drug development process
- Minimum experience of 3 years in Development
- Excellent collaboration and interpersonal skills
- Strong organizational skills
- Strong attention to detail
- Effective written and verbal communication skills
- Prior experience working in clinical research
- Medical knowledge and ability to learn relevant areas
- Ability to work in a remote environment
- Positive approach to change management
- Championing efficient methods for clinical trials
- Team oriented and flexible
- Understanding impact of technology on projects
Aufgaben
- Support the local study team in achieving quality and timely study deliverables
- Set up and maintain the electronic Trial Master File (eTMF)
- Track regulatory documents and team training documentation
- Manage milestones in the Clinical Trial Management System (CTMS)
- Assist with start-up activities, including CDA delivery and negotiation
- Distribute and collect documents during contract negotiation
- Prepare Site Files and obtain site activation approvals
- Collaborate with PMCO, CRAs, SSU manager, and study vendors
- Act as a central point of contact for project communications and documentation
- Contribute to the development and maintenance of project management tools
- Collaborate on global initiatives to standardize processes
- Assist with local language translations and submissions to IRB/CEC/CA
- Support local COM team with face-to-face study and team meetings
- Assist with team teleconferences and staff onboarding
Berufserfahrung
- 3 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- MS Office Suite
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Alexion Pharma Germany Company 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 Pharma Germany Company
Branche
Pharmaceuticals
Beschreibung
Alexion is a biopharmaceutical company focused on developing and delivering life-changing therapies for patients with rare diseases.
Noch nicht perfekt?
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