PSI CRO
Senior / Clinical Research Associate(m/w/x)
Vollzeitmit HomeofficeSenior
München
Neuer Job?Nejo!
Die KI-Suchmaschine für Jobs
PPPPD Germany GmbH & Co KG
CRA II / Sr CRA - FSP Vaccines(m/w/x)
München
VollzeitRemoteJunior
Nejo KI-Zusammenfassung
Remote and on-site monitoring of vaccine clinical trials for a global FSP provider. Experience in Oncology and Vaccine studies preferred. Regular travel for on-site monitoring visits.
Anforderungen
- Degree in life sciences, Nursing certification, or equivalent
- Experience comparable to 1 year clinical monitoring
- Valid driver's license
- Equivalent combination of education and experience
- Experience in Oncology and Vaccine studies
- Proven clinical monitoring skills
- Medical terminology and therapeutic area knowledge
- Knowledge of ICH GCPs and regulations
- Critical thinking and problem solving skills
- Ability to manage Risk Based Monitoring
- Good oral and written communication skills
- Customer focus and listening skills
- Organizational and time management skills
- Effective interpersonal skills
- Attention to detail
- Flexibility and adaptability
- Ability to work independently or in teams
- Good computer skills and Microsoft Office
- Fluency in English and German
- Good presentation skills
- Willingness for frequent travel and driving
Aufgaben
- Conduct remote and on-site monitoring visits
- Assess protocol and regulatory compliance
- Manage clinical monitoring and site management
- Follow sponsor-specific procedures and guidelines
- Ensure adherence to ICH-GCP and SOPs
- Guarantee subject well-being and data reliability
- Maintain audit readiness at all times
- Develop collaborative relationships with investigational sites
- Apply risk-based monitoring and root cause analysis
- Identify site process failures and corrective actions
- Verify data accuracy through SDR and SDV
- Perform physical inventory of investigational products
- Document observations in reports and letters
- Escalate and resolve observed deficiencies
- Maintain regular contact with investigative sites
- Execute tasks per the approved monitoring plan
- Participate in the investigator payment process
- Collaborate with team members on finding resolutions
- Attend and participate in investigator meetings
- Identify and qualify potential investigative sites
- Initiate clinical trial sites per regulations
- Perform trial close-out and material retrieval
- Ensure essential documents are complete
- Conduct on-site file reviews
- Provide trial status updates to management
- Update clinical trial management systems
- Facilitate communication between sites and clients
- Respond to regulatory audits and inspections
- Complete expense reports and timesheets
- Assist with project publications and tools
- Contribute to process improvement initiatives
Berufserfahrung
- 1 Jahr
Ausbildung
- Abgeschlossene BerufsausbildungODER
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
Tools & Technologien
- Microsoft Office
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.
Noch nicht perfekt?
- IQVIA Biotech
Clinical Research Associate 2(m/w/x)
VollzeitRemoteBerufserfahrenFrankfurt am Main, München, Hamburg - Immatics Biotechnologies GmbH
Medical Monitor*(m/w/x)
Vollzeit/Teilzeitmit HomeofficeBerufserfahrenTübingen, München - Immatics Biotechnologies GmbH
Medical Monitor*(m/w/x)
Vollzeit/Teilzeitmit HomeofficeBerufserfahrenTübingen, München, Berlin - Immatics Biotechnologies GmbH
GCP/ GCLP Auditor as Senior Manager Clinical Quality Assurance(m/w/x)
Vollzeit/Teilzeitmit HomeofficeSeniorTübingen, München
PPPPD Germany GmbH & Co KG
CRA II / Sr CRA - FSP Vaccines(m/w/x)
München
VollzeitRemoteJunior
Nejo KI-Zusammenfassung
Remote and on-site monitoring of vaccine clinical trials for a global FSP provider. Experience in Oncology and Vaccine studies preferred. Regular travel for on-site monitoring visits.
Anforderungen
- Degree in life sciences, Nursing certification, or equivalent
- Experience comparable to 1 year clinical monitoring
- Valid driver's license
- Equivalent combination of education and experience
- Experience in Oncology and Vaccine studies
- Proven clinical monitoring skills
- Medical terminology and therapeutic area knowledge
- Knowledge of ICH GCPs and regulations
- Critical thinking and problem solving skills
- Ability to manage Risk Based Monitoring
- Good oral and written communication skills
- Customer focus and listening skills
- Organizational and time management skills
- Effective interpersonal skills
- Attention to detail
- Flexibility and adaptability
- Ability to work independently or in teams
- Good computer skills and Microsoft Office
- Fluency in English and German
- Good presentation skills
- Willingness for frequent travel and driving
Aufgaben
- Conduct remote and on-site monitoring visits
- Assess protocol and regulatory compliance
- Manage clinical monitoring and site management
- Follow sponsor-specific procedures and guidelines
- Ensure adherence to ICH-GCP and SOPs
- Guarantee subject well-being and data reliability
- Maintain audit readiness at all times
- Develop collaborative relationships with investigational sites
- Apply risk-based monitoring and root cause analysis
- Identify site process failures and corrective actions
- Verify data accuracy through SDR and SDV
- Perform physical inventory of investigational products
- Document observations in reports and letters
- Escalate and resolve observed deficiencies
- Maintain regular contact with investigative sites
- Execute tasks per the approved monitoring plan
- Participate in the investigator payment process
- Collaborate with team members on finding resolutions
- Attend and participate in investigator meetings
- Identify and qualify potential investigative sites
- Initiate clinical trial sites per regulations
- Perform trial close-out and material retrieval
- Ensure essential documents are complete
- Conduct on-site file reviews
- Provide trial status updates to management
- Update clinical trial management systems
- Facilitate communication between sites and clients
- Respond to regulatory audits and inspections
- Complete expense reports and timesheets
- Assist with project publications and tools
- Contribute to process improvement initiatives
Berufserfahrung
- 1 Jahr
Ausbildung
- Abgeschlossene BerufsausbildungODER
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
Tools & Technologien
- Microsoft Office
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?
- PSI CRO
Senior / Clinical Research Associate(m/w/x)
Vollzeitmit HomeofficeSeniorMünchen - IQVIA Biotech
Clinical Research Associate 2(m/w/x)
VollzeitRemoteBerufserfahrenFrankfurt am Main, München, Hamburg - Immatics Biotechnologies GmbH
Medical Monitor*(m/w/x)
Vollzeit/Teilzeitmit HomeofficeBerufserfahrenTübingen, München - Immatics Biotechnologies GmbH
Medical Monitor*(m/w/x)
Vollzeit/Teilzeitmit HomeofficeBerufserfahrenTübingen, München, Berlin - Immatics Biotechnologies GmbH
GCP/ GCLP Auditor as Senior Manager Clinical Quality Assurance(m/w/x)
Vollzeit/Teilzeitmit HomeofficeSeniorTübingen, München