BP13 Alexion Pharma Germany Company
Country Study Manager(m/w/x)
Full-timeOn-siteExperienced
München
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ALAlexion
Clinical Research Associate(m/w/x)
München
Full-timeOn-siteManagement
Nejo AI Summary
Site identification, monitoring, and closeout visits for pharmaceutical trials. 1 year monitoring experience required. Work across diverse therapeutic areas.
Requirements
- 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
Tasks
- 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.
Work Experience
- 1 year
Education
- Bachelor's degree
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Alexion 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
Clinical Research Associate(m/w/x)
München
Full-timeOn-siteManagement
Nejo AI Summary
Site identification, monitoring, and closeout visits for pharmaceutical trials. 1 year monitoring experience required. Work across diverse therapeutic areas.
Requirements
- 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
Tasks
- 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.
Work Experience
- 1 year
Education
- Bachelor's degree
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Alexion 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
Industry
Pharmaceuticals
Description
Alexion develops and sells life-changing drugs for rare and severe diseases, including neuroscience, aiming for excellent treatment outcomes.
Not a perfect match?
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