BP13 Alexion Pharma Germany Company
Country Study Manager(m/w/x)
Full-timeOn-siteExperienced
München
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ALAlexion Pharma Germany Company
Senior Clinical Study Administrator(m/w/x)
München
Full-timeOn-siteSenior
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 3 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- MS Office Suite
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Alexion Pharma Germany Company and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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ALAlexion Pharma Germany Company
Senior Clinical Study Administrator(m/w/x)
München
Full-timeOn-siteSenior
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 3 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- MS Office Suite
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Alexion Pharma Germany Company and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Alexion Pharma Germany Company
Industry
Pharmaceuticals
Description
Alexion is a biopharmaceutical company focused on developing and delivering life-changing therapies for patients with rare diseases.
Not a perfect match?
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