BeOne Medicines I GmbH
Associate Director, Good Clinical Practice (GCP) Audit and Vendor Management(m/w/x)
Vollzeitnur vor OrtSenior
Basel
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
BEBeOne Medicines I GmbH
Regional Clinical Compliance Director/ Senior Director(m/w/x)
Basel
VollzeitVor OrtManagement
Nejo KI-Zusammenfassung
Oversight of global clinical compliance strategies for cancer research studies. Expertise in GCP and clinical operations required. International travel to study sites.
Anforderungen
- Expertise in GCP and clinical operations
- High level of clinical operations knowledge
- Strong analytical and managerial skills
- Appropriate escalation of quality issues
- Excellent English communication and interpersonal skills
- Excellent organizational, presentation, and training skills
- Ability to work independently in multi-cultural settings
- Bachelor’s degree in scientific, medical, or healthcare discipline
- Minimum 14 years’ experience in GCP compliance or equivalent role
- Experience in oncology global trials
- PC literacy and MSOffice skills
Aufgaben
- Implement Global Clinical Compliance strategies
- Provide compliance oversight for assigned studies
- Ensure inspection readiness and regulatory compliance
- Identify and escalate non-compliance issues
- Track non-compliance issues and quality events
- Support GCP readiness activities and programs
- Adhere to ICH/GCP and local regulations
- Contribute to Clinical Operations Work Instructions and SOPs
- Demonstrate clinical study experience and trial management
- Support inspection preparation and response management
- Lead and guide Regional Clinical Compliance stakeholders
- Foster collaboration with key stakeholders
- Draft responses and corrective action plans for audits
- Identify compliance matters and drive improvements
- Provide GCP compliance guidance to stakeholders
- Ensure escalation of GCP non-compliance issues
- Develop and implement CAPA for compliance issues
- Manage Site & Sponsor inspections
- Develop GCP inspection readiness programs
- Feed audit findings into training materials
- Approve compliance visit scheduling and preparation
- Peer review compliance assessment reports
- Monitor Key Compliance Indicators and develop metrics
- Conduct trend analysis for compliance risks
- Establish preventive action initiatives
- Drive internal GCP compliance process improvements
- Lead GCP compliance training material development
- Provide expertise on clinical trial processes
- Offer feedback on investigator site performance
- Stay updated on regulations and industry trends
- Oversee direct/indirect reports' work
- Conduct regular performance appraisals and feedback
- Engage in career development planning for team members
- Mentor Clinical Compliance team members
Berufserfahrung
- 14 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- MSOffice
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens BeOne Medicines I GmbH 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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BEBeOne Medicines I GmbH
Regional Clinical Compliance Director/ Senior Director(m/w/x)
Basel
VollzeitVor OrtManagement
Nejo KI-Zusammenfassung
Oversight of global clinical compliance strategies for cancer research studies. Expertise in GCP and clinical operations required. International travel to study sites.
Anforderungen
- Expertise in GCP and clinical operations
- High level of clinical operations knowledge
- Strong analytical and managerial skills
- Appropriate escalation of quality issues
- Excellent English communication and interpersonal skills
- Excellent organizational, presentation, and training skills
- Ability to work independently in multi-cultural settings
- Bachelor’s degree in scientific, medical, or healthcare discipline
- Minimum 14 years’ experience in GCP compliance or equivalent role
- Experience in oncology global trials
- PC literacy and MSOffice skills
Aufgaben
- Implement Global Clinical Compliance strategies
- Provide compliance oversight for assigned studies
- Ensure inspection readiness and regulatory compliance
- Identify and escalate non-compliance issues
- Track non-compliance issues and quality events
- Support GCP readiness activities and programs
- Adhere to ICH/GCP and local regulations
- Contribute to Clinical Operations Work Instructions and SOPs
- Demonstrate clinical study experience and trial management
- Support inspection preparation and response management
- Lead and guide Regional Clinical Compliance stakeholders
- Foster collaboration with key stakeholders
- Draft responses and corrective action plans for audits
- Identify compliance matters and drive improvements
- Provide GCP compliance guidance to stakeholders
- Ensure escalation of GCP non-compliance issues
- Develop and implement CAPA for compliance issues
- Manage Site & Sponsor inspections
- Develop GCP inspection readiness programs
- Feed audit findings into training materials
- Approve compliance visit scheduling and preparation
- Peer review compliance assessment reports
- Monitor Key Compliance Indicators and develop metrics
- Conduct trend analysis for compliance risks
- Establish preventive action initiatives
- Drive internal GCP compliance process improvements
- Lead GCP compliance training material development
- Provide expertise on clinical trial processes
- Offer feedback on investigator site performance
- Stay updated on regulations and industry trends
- Oversee direct/indirect reports' work
- Conduct regular performance appraisals and feedback
- Engage in career development planning for team members
- Mentor Clinical Compliance team members
Berufserfahrung
- 14 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- MSOffice
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens BeOne Medicines I GmbH 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
BeOne Medicines I GmbH
Branche
Healthcare
Beschreibung
The company is focused on fighting cancer and offers opportunities for scientific and business professionals.
Noch nicht perfekt?
- BeOne Medicines I GmbH
Associate Director, Good Clinical Practice (GCP) Audit and Vendor Management(m/w/x)
Vollzeitnur vor OrtSeniorBasel - BeOne Medicines I GmbH
Senior Manager, GCP Inspection Lead(m/w/x)
Vollzeitnur vor OrtSeniorBaselab CHF 141.800 - 177.300 / Jahr - Idorsia Pharmaceuticals Ltd
Senior Clinical QA Manager(m/w/x)
Vollzeitnur vor OrtSeniorBasel - BeOne Medicines I GmbH
Associate Director, Regional Program Lead(m/w/x)
Vollzeitnur vor OrtManagementBasel - BeOne Medicines I GmbH
Regional Clinical Study Manager(m/w/x)
Vollzeitnur vor OrtBerufserfahrenBaselab CHF 124.800 - 156.000 / Jahr