Genmab
Senior Manager, Inspection Readiness - GCP
DanmarkPosted 10 days ago
Full TimeSeniorDK
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Job Description
We are extra[not]ordinary *(ex· tra· not· or· di· nary |\ ik-ˈstr-not-ȯr-də-ˌner-ē) Adjective: A unique word for Genmab meaning to go way beyond what is usual; to be remarkable; proudly unique and aut
Key Highlights
- Design and optimize tools and processes for trial inspection readiness, leveraging digitalization and automation to improve efficiency and compliance.
- Drive continuous assessments of compound and/or trial inspection readiness by analysing key metrics to interpret and generate actionable insights.
- Lead the development and delivery of GCP inspection readiness training/tools for Clinical Trial Operations and other key stakeholders.
- Collaborate closely with GCP QA and support the operational framework and inspection setup during sponsor and site/vendor GCP inspections.
- Develop and conduct lessons learned from inspection readiness, preparations and outcomes within Clinical Trial Operations.
Qualifications
Required Qualifications
- Master’s (MSc) degree in Life Sciences, Pharmacy, Medicine or a related discipline.
- Minimum of 8 years of experience in Clinical Operations, Clinical Quality, Inspection Readiness or Clinical Compliance role within the pharmaceutical or biotechnology industry.
- Strong understanding of clinical trial processes, ICH-GCP & regulations, and the clinical drug development lifecycle.
- Project management skills and knowledge of tools and processes.
- Experience mentoring and supporting the development of colleagues.
- Excellent written and verbal communication skills.
- Ability to proactively identify risks, develop mitigation strategies, and effectively resolve issues.
- Strong stakeholder management skills with the ability to collaborate effectively across functions working in a complex, global, and matrix organization.
Skills & Technologies
GoGCP
About the Company
Genmab
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Job Details
Employment Type
Full Time
Experience Level
Senior
Location
Danmark
Posted
10 days ago
Country
DK