Thermo Fisher Scientific
Clinical Trial Coordinator II(m/w/x)
Full-timeWith HomeofficeExperienced
Karlsruhe
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BEBecton Dickinson
Senior Clinical Project Manager(m/w/x)
Karlsruhe
Full-timeWith Home OfficeSenior
Nejo AI Summary
Overseeing clinical trials for medical device/IVD technologies, mentoring junior PMs and CRAs. 6 years clinical study experience in medical device/IVD/pharma/biotech/CRO, 4 years project management experience required. Work with innovative patient care technologies.
Requirements
- Bachelor's degree in life sciences or relevant technical areas
- Minimum 4 years project management experience
- Minimum 6 years of clinical study experience in medical device, IVD, pharmaceutical, biotechnology, or CRO
- Familiarity with CLSI guidelines and other standards
- Demonstrable Project Management skills; PMP Certification preferred
- Proficient understanding of Good Clinical Practice (GCP), FDA and ISO regulations, MDR/IVDR
- Knowledge of clinical trial concepts and practices
- Strong client and vendor relationship management skills
- Ability to work effectively in international teams and manage multiple projects
- Effective interpersonal, communications and negotiation skills
- Ability to work effectively in a virtual environment
- Ability to travel approximately 20%, worldwide
Tasks
- Manage clinical trials for multiple studies
- Serve as a subject matter expert for assigned clinical studies
- Plan and implement clinical trial activities
- Oversee project management and completion of trials
- Mentor Clinical Project Managers and CRAs
- Lead high-complexity studies from protocol development to closeout
- Ensure compliance with Good Clinical Practices and regulations
- Collaborate with the Clinical Program Manager and Director
- Review business requests and develop study execution plans
- Identify and manage project risks and issues
- Collaborate with global project management, data management, and statistics
- Work with Medical Affairs departments on study-related activities
- Train local clinical resources and oversee contractors
- Implement high-quality standards for study compliance
- Contribute to continuous improvement initiatives
- Manage relationships with sites, PIs, and vendors
- Develop and oversee clinical study budgets
- Review and approve invoices and monthly accruals
- Track and report on project management schedules and deliverables
Work Experience
- 6 years
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 Becton Dickinson 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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BEBecton Dickinson
Senior Clinical Project Manager(m/w/x)
Karlsruhe
Full-timeWith Home OfficeSenior
Nejo AI Summary
Overseeing clinical trials for medical device/IVD technologies, mentoring junior PMs and CRAs. 6 years clinical study experience in medical device/IVD/pharma/biotech/CRO, 4 years project management experience required. Work with innovative patient care technologies.
Requirements
- Bachelor's degree in life sciences or relevant technical areas
- Minimum 4 years project management experience
- Minimum 6 years of clinical study experience in medical device, IVD, pharmaceutical, biotechnology, or CRO
- Familiarity with CLSI guidelines and other standards
- Demonstrable Project Management skills; PMP Certification preferred
- Proficient understanding of Good Clinical Practice (GCP), FDA and ISO regulations, MDR/IVDR
- Knowledge of clinical trial concepts and practices
- Strong client and vendor relationship management skills
- Ability to work effectively in international teams and manage multiple projects
- Effective interpersonal, communications and negotiation skills
- Ability to work effectively in a virtual environment
- Ability to travel approximately 20%, worldwide
Tasks
- Manage clinical trials for multiple studies
- Serve as a subject matter expert for assigned clinical studies
- Plan and implement clinical trial activities
- Oversee project management and completion of trials
- Mentor Clinical Project Managers and CRAs
- Lead high-complexity studies from protocol development to closeout
- Ensure compliance with Good Clinical Practices and regulations
- Collaborate with the Clinical Program Manager and Director
- Review business requests and develop study execution plans
- Identify and manage project risks and issues
- Collaborate with global project management, data management, and statistics
- Work with Medical Affairs departments on study-related activities
- Train local clinical resources and oversee contractors
- Implement high-quality standards for study compliance
- Contribute to continuous improvement initiatives
- Manage relationships with sites, PIs, and vendors
- Develop and oversee clinical study budgets
- Review and approve invoices and monthly accruals
- Track and report on project management schedules and deliverables
Work Experience
- 6 years
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 Becton Dickinson 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.
About the Company
Becton Dickinson
Industry
Healthcare
Description
The company develops innovative technologies and services to improve patient care and clinical workflows.
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