Thermo Fisher Scientific
Assistant CRA - FSP(m/w/x)
VollzeitRemoteBerufseinsteiger
Karlsruhe
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
HRHRA 11164 PPD Germany GmbH & Co KG
CRA I/II - Klinischer Monitor(m/w/x)
Karlsruhe, München
VollzeitRemoteBerufserfahren
Nejo KI-Zusammenfassung
On-site and remote monitoring of clinical trials for life-changing therapies. Ensuring subject rights, well-being, and data reliability required. Home-based option, permanent full-time.
Anforderungen
- Bachelor's degree in life sciences or equivalent qualification
- Previous experience providing job knowledge, skills, and abilities
- Valid driver's license
- Full right to work in Germany
- English and German language fluency (C1 level)
- Effective clinical monitoring skills
- Understanding of medical/therapeutic area knowledge and terminology
- Understanding and application of ICH GCPs, regulations, and procedural documents
- Critical thinking skills for root cause analysis and decision-making
- Ability to handle Risk Based Monitoring concepts and processes
- Effective oral and written communication skills with medical personnel
- Customer focus through listening, attention to detail, and issue perception
- Strong attention to detail
- Effective organizational and time management skills
- Flexibility and adaptability in various scenarios
- Ability to work in a team or independently
- Proficient Microsoft Office skills and ability to learn software
- Good presentation skills
- Severely disabled applicants with same aptitude given preferential treatment
Aufgaben
- Conduct remote or on-site visits to assess protocol and regulatory compliance
- Manage required documentation for clinical trials
- Ensure trial adherence to approved protocol, ICH-GCP guidelines, and regulations
- Guarantee subjects' rights, well-being, and data reliability
- Maintain audit readiness
- Develop collaborative relationships with investigational sites
- Monitor investigator sites using risk-based monitoring approach
- Apply root cause analysis and problem-solving skills to identify and correct site issues
- Ensure data accuracy through source data review, source data verification, and CRF review
- Assess investigational product through physical inventory and records review
- Document observations in reports and letters using approved standards
- Report observed deficiencies and issues to clinical management
- Maintain regular contact with investigative sites between monitoring visits
- Conduct monitoring tasks according to the approved monitoring plan
- Participate in the investigator payment process
- Collaborate with project team members on issue resolution
- Investigate and follow up on findings
- Provide trial status and progress updates to the Clinical Team Manager
- Update study systems per agreed conventions
- Perform quality control checks on reports generated from CTMS
- Participate in investigator meetings
- Identify potential investigators in collaboration with the client company
- Initiate clinical trial sites according to relevant procedures
- Ensure trial close-out and retrieval of trial materials
- Complete required essential documents according to ICH-GCP and regulations
- Conduct on-site file reviews as per project specifications
- Assist in preparation of project publications and tools
- Share ideas and suggestions with team members
- Perform additional study tasks as assigned by the Clinical Team Manager
- Facilitate communication between investigative sites, client company, and PPD project team
- Respond to company, client, and regulatory requirements/audits/inspections
- Complete administrative tasks such as expense reports and timesheets
- Contribute to project work and process improvement initiatives
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Abgeschlossene BerufsausbildungODER
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
Tools & Technologien
- Microsoft Office
Benefits
Flexibles Arbeiten
- Home-based option
- Hybrid option
Sonstige Vorteile
- Office-based in Munich
- Office-based in Karlsruhe
Sicherer Arbeitsplatz
- Permanent full-time position
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens HRA 11164 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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On-site and remote monitoring of clinical trials for life-changing therapies. Ensuring subject rights, well-being, and data reliability required. Home-based option, permanent full-time.
Anforderungen
- Bachelor's degree in life sciences or equivalent qualification
- Previous experience providing job knowledge, skills, and abilities
- Valid driver's license
- Full right to work in Germany
- English and German language fluency (C1 level)
- Effective clinical monitoring skills
- Understanding of medical/therapeutic area knowledge and terminology
- Understanding and application of ICH GCPs, regulations, and procedural documents
- Critical thinking skills for root cause analysis and decision-making
- Ability to handle Risk Based Monitoring concepts and processes
- Effective oral and written communication skills with medical personnel
- Customer focus through listening, attention to detail, and issue perception
- Strong attention to detail
- Effective organizational and time management skills
- Flexibility and adaptability in various scenarios
- Ability to work in a team or independently
- Proficient Microsoft Office skills and ability to learn software
- Good presentation skills
- Severely disabled applicants with same aptitude given preferential treatment
Aufgaben
- Conduct remote or on-site visits to assess protocol and regulatory compliance
- Manage required documentation for clinical trials
- Ensure trial adherence to approved protocol, ICH-GCP guidelines, and regulations
- Guarantee subjects' rights, well-being, and data reliability
- Maintain audit readiness
- Develop collaborative relationships with investigational sites
- Monitor investigator sites using risk-based monitoring approach
- Apply root cause analysis and problem-solving skills to identify and correct site issues
- Ensure data accuracy through source data review, source data verification, and CRF review
- Assess investigational product through physical inventory and records review
- Document observations in reports and letters using approved standards
- Report observed deficiencies and issues to clinical management
- Maintain regular contact with investigative sites between monitoring visits
- Conduct monitoring tasks according to the approved monitoring plan
- Participate in the investigator payment process
- Collaborate with project team members on issue resolution
- Investigate and follow up on findings
- Provide trial status and progress updates to the Clinical Team Manager
- Update study systems per agreed conventions
- Perform quality control checks on reports generated from CTMS
- Participate in investigator meetings
- Identify potential investigators in collaboration with the client company
- Initiate clinical trial sites according to relevant procedures
- Ensure trial close-out and retrieval of trial materials
- Complete required essential documents according to ICH-GCP and regulations
- Conduct on-site file reviews as per project specifications
- Assist in preparation of project publications and tools
- Share ideas and suggestions with team members
- Perform additional study tasks as assigned by the Clinical Team Manager
- Facilitate communication between investigative sites, client company, and PPD project team
- Respond to company, client, and regulatory requirements/audits/inspections
- Complete administrative tasks such as expense reports and timesheets
- Contribute to project work and process improvement initiatives
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Abgeschlossene BerufsausbildungODER
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
Tools & Technologien
- Microsoft Office
Benefits
Flexibles Arbeiten
- Home-based option
- Hybrid option
Sonstige Vorteile
- Office-based in Munich
- Office-based in Karlsruhe
Sicherer Arbeitsplatz
- Permanent full-time position
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens HRA 11164 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.
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
HRA 11164 PPD Germany GmbH & Co KG
Branche
Pharmaceuticals
Beschreibung
The company enables customers to make the world healthier, cleaner and safer through clinical research and development.
Noch nicht perfekt?
- Thermo Fisher Scientific
Assistant CRA - FSP(m/w/x)
VollzeitRemoteBerufseinsteigerKarlsruhe - Thermo Fisher Scientific
Clinical Trial Coordinator II(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenKarlsruhe - HRA 11164 PPD Germany GmbH & Co KG
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Tumordokumentar(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenKarlsruhe