Thermo Fisher Scientific
Clinical Trial Coordinator II(m/w/x)
Vollzeitmit HomeofficeBerufserfahren
Karlsruhe
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
BEBecton Dickinson
Senior Clinical Project Manager(m/w/x)
Karlsruhe
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 6 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Becton Dickinson 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?
- Devoteam
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BEBecton Dickinson
Senior Clinical Project Manager(m/w/x)
Karlsruhe
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 6 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Becton Dickinson 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
Becton Dickinson
Branche
Healthcare
Beschreibung
The company develops innovative technologies and services to improve patient care and clinical workflows.
Noch nicht perfekt?
- Thermo Fisher Scientific
Clinical Trial Coordinator II(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenKarlsruhe - Devoteam
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Vollzeitmit HomeofficeSeniorKarlsruhe - Agilent Technologies Deutschland GmbH
R&D Director - SW Engineering(m/w/x)
Vollzeitmit HomeofficeSeniorWaldbronn - init innovation in traffic systems
Senior Commercial Project Manager(m/w/x)
Vollzeitmit HomeofficeSeniorKarlsruhe - Agilent Technologies Deutschland GmbH
R&D Scientist – Biopharma LC Instrumentation(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenWaldbronn, München, Frankfurt am Main, Hamburg, Ratingen