Thermo Fisher Scientific
Clinical Trial Coordinator II(m/w/x)
Vollzeitmit HomeofficeBerufserfahren
Karlsruhe
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
PPPPD Germany GmbH & Co KG
Clinical Trial Coordinator - FSP(m/w/x)
Karlsruhe
Vollzeitmit Homeoffice
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – fließend
- Deutsch – verhandlungssicher
Tools & Technologien
- MS Office
- Word
- Excel
- PowerPoint
- clinical trial database systems
Benefits
Flexibles Arbeiten
- Flexible working models
- Flexible working culture
Familienfreundlichkeit
- Work-life balance support
Gesundheits- & Fitnessangebote
- Health and well-being benefits
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens PPD Germany GmbH & Co KG erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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PPPPD Germany GmbH & Co KG
Clinical Trial Coordinator - FSP(m/w/x)
Karlsruhe
Vollzeitmit Homeoffice
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – fließend
- Deutsch – verhandlungssicher
Tools & Technologien
- MS Office
- Word
- Excel
- PowerPoint
- clinical trial database systems
Benefits
Flexibles Arbeiten
- Flexible working models
- Flexible working culture
Familienfreundlichkeit
- Work-life balance support
Gesundheits- & Fitnessangebote
- Health and well-being benefits
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens PPD Germany GmbH & Co KG erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Über das Unternehmen
PPD Germany GmbH & Co KG
Branche
Pharmaceuticals
Beschreibung
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.
Noch nicht perfekt?
- Thermo Fisher Scientific
Clinical Trial Coordinator II(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenKarlsruhe - Thermo Fisher Scientific
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Tumordokumentar(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenKarlsruhe