Fresenius Kabi Deutschland GmbH
Senior Launch Manager(m/w/x)
Full-timeOn-siteSenior
Bad Homburg vor der Höhe
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FRFresenius Kabi Deutschland GmbH
Senior Manager Clinical Operations(m/w/x)
Bad Homburg vor der Höhe
Full-timeOn-siteSenior
Nejo AI Summary
Overseeing national/international clinical trials for medical nutrition and anesthetics. Master's in life sciences and 5+ years as clinical trial manager required. Frequent international project coordination.
Requirements
- Master’s degree in life sciences, pharmacy, or related field
- At least 5 years of experience as clinical trial manager
- Hands-on experience with project management tools or certification
- Strong knowledge of GCP, ICH guidelines, and regulatory requirements
- Proficiency in Microsoft Office tools
- Excellent project management skills
- Ability to work effectively in international teams
- Excellent communication skills, spoken and written (English)
Tasks
- Plan and organize national and international clinical trials
- Execute and oversee clinical trials focusing on nutrition studies
- Manage clinical studies according to EU, US, and PhM requirements
- Develop detailed project plans, timelines, and budget estimates
- Select, instruct, and supervise Contract Research Organizations (CROs)
- Collaborate with external service providers, including consultants and medical experts
- Engage in cross-functional collaboration with Regulatory Affairs and Drug Safety teams
- Design and develop clinical study protocols and case report forms (CRFs)
- Review clinical study reports and analytical method validation documents
- Compile regulatory documents, including clinical trial applications and amendments
- Respond to queries from regulatory authorities and ethics committees
- Ensure compliance with regulatory requirements and standards
- Monitor and supervise study sites to ensure data integrity
- Set up and maintain the trial master file (TMF)
- Safeguard study documentation
- Generate monthly status reports for internal reporting
Work Experience
- 5 years
Education
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- Microsoft Office
- clinical trial management software
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Fresenius Kabi Deutschland GmbH 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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FRFresenius Kabi Deutschland GmbH
Senior Manager Clinical Operations(m/w/x)
Bad Homburg vor der Höhe
Full-timeOn-siteSenior
Nejo AI Summary
Overseeing national/international clinical trials for medical nutrition and anesthetics. Master's in life sciences and 5+ years as clinical trial manager required. Frequent international project coordination.
Requirements
- Master’s degree in life sciences, pharmacy, or related field
- At least 5 years of experience as clinical trial manager
- Hands-on experience with project management tools or certification
- Strong knowledge of GCP, ICH guidelines, and regulatory requirements
- Proficiency in Microsoft Office tools
- Excellent project management skills
- Ability to work effectively in international teams
- Excellent communication skills, spoken and written (English)
Tasks
- Plan and organize national and international clinical trials
- Execute and oversee clinical trials focusing on nutrition studies
- Manage clinical studies according to EU, US, and PhM requirements
- Develop detailed project plans, timelines, and budget estimates
- Select, instruct, and supervise Contract Research Organizations (CROs)
- Collaborate with external service providers, including consultants and medical experts
- Engage in cross-functional collaboration with Regulatory Affairs and Drug Safety teams
- Design and develop clinical study protocols and case report forms (CRFs)
- Review clinical study reports and analytical method validation documents
- Compile regulatory documents, including clinical trial applications and amendments
- Respond to queries from regulatory authorities and ethics committees
- Ensure compliance with regulatory requirements and standards
- Monitor and supervise study sites to ensure data integrity
- Set up and maintain the trial master file (TMF)
- Safeguard study documentation
- Generate monthly status reports for internal reporting
Work Experience
- 5 years
Education
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- Microsoft Office
- clinical trial management software
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Fresenius Kabi Deutschland GmbH 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
Fresenius Kabi Deutschland GmbH
Industry
Healthcare
Description
Das Unternehmen repräsentiert Produkte und Dienstleistungen im Bereich Trinknahrung und Anästhetika.
Not a perfect match?
- Fresenius Kabi Deutschland GmbH
Senior Launch Manager(m/w/x)
Full-timeOn-siteSeniorBad Homburg vor der Höhe - Fresenius Kabi Deutschland GmbH
(Senior) Preclinical Innovation Manager(m/w/x)
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Senior Manager Biostatistics(m/w/x)
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Full-timeOn-siteSeniorBad Homburg vor der Höhe