BeOne Medicines I GmbH
Associate Director, Good Clinical Practice (GCP) Audit and Vendor Management(m/w/x)
Full-timeOn-siteSenior
Basel
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BEBeOne Medicines I GmbH
Regional Clinical Compliance Director/ Senior Director(m/w/x)
Basel
Full-timeOn-siteManagement
Nejo AI Summary
Oversight of global clinical compliance strategies for cancer research studies. Expertise in GCP and clinical operations required. International travel to study sites.
Requirements
- 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
Tasks
- 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
Work Experience
- 14 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- MSOffice
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of BeOne Medicines I GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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BEBeOne Medicines I GmbH
Regional Clinical Compliance Director/ Senior Director(m/w/x)
Basel
Full-timeOn-siteManagement
Nejo AI Summary
Oversight of global clinical compliance strategies for cancer research studies. Expertise in GCP and clinical operations required. International travel to study sites.
Requirements
- 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
Tasks
- 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
Work Experience
- 14 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- MSOffice
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of BeOne Medicines I GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
BeOne Medicines I GmbH
Industry
Healthcare
Description
The company is focused on fighting cancer and offers opportunities for scientific and business professionals.
Not a perfect match?
- BeOne Medicines I GmbH
Associate Director, Good Clinical Practice (GCP) Audit and Vendor Management(m/w/x)
Full-timeOn-siteSeniorBasel - Idorsia Pharmaceuticals Ltd
Senior Clinical QA Manager(m/w/x)
Full-timeOn-siteSeniorBasel - BeOne Medicines I GmbH
Associate Director, Regional Program Lead(m/w/x)
Full-timeOn-siteManagementBasel - Roche
Head of Compliance and Quality Governance(m/w/x)
Full-timeOn-siteSeniorKaiseraugst - 1201 F. Hoffmann-La Roche AG
Affiliate Network Regional Quality Lead(m/w/x)
Full-timeOn-siteExperiencedBasel