Thermo Fisher Scientific
Clinical Trial Coordinator II(m/w/x)
Full-timeWith HomeofficeExperienced
Karlsruhe
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PPPPD Germany GmbH & Co KG
Clinical Trial Coordinator - FSP(m/w/x)
Karlsruhe
Full-timeWith Home Office
Nejo AI Summary
Coordinating clinical trial activities and performing file reviews for global life sciences research. University degree in life sciences or equivalent required. Flexible working models, work-life balance support.
Requirements
- University degree in life sciences or equivalent
- Teamwork and independent work ability
- Good organizational skills and attention to detail
- Efficient and effective multi-tasking
- Data/system analysis for accuracy and efficiency
- Strong customer focus
- Workload reprioritization for project timelines
- Knowledge of Country Regulations, ICH GCP, SOPs, WPDs
- Excellent English language skills
- German (C1 level) language skills
- Advanced digital literacy
- Proficiency in MS Office (Word, Excel, PowerPoint)
- Ability to master clinical trial database systems
- Ability to complete PPD clinical training
- Self-motivation and positive attitude
- Good interpersonal skills
- Preferential treatment for severely disabled applicants
- Preferential consideration for severely disabled applicants
Tasks
- Provide administrative and technical support to the Project Team
- Coordinate and complete assigned trial activities
- Perform and document file reviews for department, country, and investigators
- Ensure tasks are completed on time, within budget, and to high standards
- Communicate risks proactively to project leads
- Maintain study-specific documentation and systems
- Manage study team lists, training requirements, and system access
- Track project-level activity plans
- Provide system support for GoBalto and eTMF
- Support Risk-Based Monitoring (RBM) activities
- Process documents for client (e)TMF
- Perform (e)TMF reviews
- Handle mass mailings and internal communications
- Provide documents and reports to internal team members
- Schedule client and internal meetings
- Review and track local regulatory documents
- Transmit documents to client and centralized IRB/IEC
- Analyze and reconcile study metrics and findings reports
- Assist with clarification and resolution of site documentation issues
- Maintain vendor trackers
- Coordinate and distribute Investigator Site File (ISF) and Pharmacy binder materials
- Manage non-clinical study supplies to sites
- Assist with study-specific translation materials and translation QC
Education
- Bachelor's degree
Languages
- English – Native
- German – Business Fluent
Tools & Technologies
- MS Office
- Word
- Excel
- PowerPoint
- clinical trial database systems
Benefits
Flexible Working
- Flexible working models
- Flexible working culture
Family Support
- Work-life balance support
Healthcare & Fitness
- Health and well-being benefits
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of PPD Germany GmbH & Co KG 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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PPPPD Germany GmbH & Co KG
Clinical Trial Coordinator - FSP(m/w/x)
Karlsruhe
Full-timeWith Home Office
Nejo AI Summary
Coordinating clinical trial activities and performing file reviews for global life sciences research. University degree in life sciences or equivalent required. Flexible working models, work-life balance support.
Requirements
- University degree in life sciences or equivalent
- Teamwork and independent work ability
- Good organizational skills and attention to detail
- Efficient and effective multi-tasking
- Data/system analysis for accuracy and efficiency
- Strong customer focus
- Workload reprioritization for project timelines
- Knowledge of Country Regulations, ICH GCP, SOPs, WPDs
- Excellent English language skills
- German (C1 level) language skills
- Advanced digital literacy
- Proficiency in MS Office (Word, Excel, PowerPoint)
- Ability to master clinical trial database systems
- Ability to complete PPD clinical training
- Self-motivation and positive attitude
- Good interpersonal skills
- Preferential treatment for severely disabled applicants
- Preferential consideration for severely disabled applicants
Tasks
- Provide administrative and technical support to the Project Team
- Coordinate and complete assigned trial activities
- Perform and document file reviews for department, country, and investigators
- Ensure tasks are completed on time, within budget, and to high standards
- Communicate risks proactively to project leads
- Maintain study-specific documentation and systems
- Manage study team lists, training requirements, and system access
- Track project-level activity plans
- Provide system support for GoBalto and eTMF
- Support Risk-Based Monitoring (RBM) activities
- Process documents for client (e)TMF
- Perform (e)TMF reviews
- Handle mass mailings and internal communications
- Provide documents and reports to internal team members
- Schedule client and internal meetings
- Review and track local regulatory documents
- Transmit documents to client and centralized IRB/IEC
- Analyze and reconcile study metrics and findings reports
- Assist with clarification and resolution of site documentation issues
- Maintain vendor trackers
- Coordinate and distribute Investigator Site File (ISF) and Pharmacy binder materials
- Manage non-clinical study supplies to sites
- Assist with study-specific translation materials and translation QC
Education
- Bachelor's degree
Languages
- English – Native
- German – Business Fluent
Tools & Technologies
- MS Office
- Word
- Excel
- PowerPoint
- clinical trial database systems
Benefits
Flexible Working
- Flexible working models
- Flexible working culture
Family Support
- Work-life balance support
Healthcare & Fitness
- Health and well-being benefits
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of PPD Germany GmbH & Co KG 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
PPD Germany GmbH & Co KG
Industry
Pharmaceuticals
Description
PPD's Functional Service Provider division partners with and serves as an extension of our PPD team, supporting our customers key functions. We cover customer needs on every level, allowing them to do more with less, with an uncompromising commitment to quality.
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