Clinical Operations Director
2 weeks ago
Job Summary
The Clinical Operations Director will be responsible for overseeing the inspection readiness of clinical trials at Genmab. This role involves cultivating an international team committed to achieving superior inspection readiness, ensuring compliance with Good Clinical Practice (GCP) and other relevant standards.
Key Responsibilities
- Direct an international team of clinical inspection readiness managers, ensuring strict adherence to GCP and leading project management efforts.
- Craft and execute comprehensive inspection readiness strategies on a global scale, maintaining close coordination with trial management and quality assurance teams.
- Utilize key performance indicators (KPIs) to monitor and enhance clinical inspection readiness, aligning efforts with both organizational objectives and regulatory requirements.
- Enhance inspection readiness processes by partnering with quality assurance to develop training, establish best practices, and spearhead process and system improvements based on audit and inspection feedback.
- Drive risk management efforts by identifying and mitigating non-compliance risks across clinical trials, working alongside quality assurance for regular audits and evaluations.
Requirements
- Advanced degree in life sciences, healthcare, or related field.
- Fluent English (oral and written).
- 12+ years' experience in managing clinical trials, focusing on quality assurance, process optimization, and regulatory compliance.
- Proven leadership in orchestrating international teams, demonstrating a capacity for effective global coordination and team management.
- Solid background in clinical operations compliance and trial master file management within the pharmaceutical or biotechnology sectors.
- Hands-on experience in sponsor-level inspection readiness, including both front and back-room inspection logistics and operations.
- Expertise in managing document records through electronic trial master file platforms, ensuring efficient and compliant documentation practices.
- Comprehensive understanding of ICH-GCP guidelines and international regulatory frameworks, with a proven track record of applying these standards in clinical research.
About Genmab
Genmab is a biotechnology company dedicated to transforming the lives of patients through innovative cancer treatment. We are committed to excellence and rigor in all that we do, and we are seeking a talented individual to join our team as a Clinical Operations Director.
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