Clinical Operations Director
5 days ago
We are seeking an exceptional Clinical Operations Director to join our team at Genmab.
This is a unique opportunity to lead our Global Inspection Readiness function, driving excellence in clinical trial management and ensuring compliance with regulatory standards. As a seasoned professional, you will oversee the readiness of clinical trial procedures and documents for regulatory scrutiny, leveraging your expertise to minimize risks and ensure trials can withstand regulatory examination.
The role offers flexibility in location, with options in the United States, Denmark, or the Netherlands. You will be responsible for direct leadership of an international team of clinical inspection readiness managers, fostering collaboration with clinical research organizations (CROs), trial teams, and quality assurance experts.
About This Opportunity- $160,000 - $220,000 per year salary range
- Leadership experience in managing clinical trials, focusing on quality assurance, process optimization, and regulatory compliance
- Proven ability to transform strategic visions into actionable operational plans
- Exceptional relationship-building skills, essential for fostering collaboration and driving proactive compliance activities across diverse teams and stakeholders
- Direct an international team of clinical inspection readiness managers, ensuring strict adherence to Good Clinical Practice (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
Genmab is a dynamic company dedicated to transforming the lives of patients through innovative cancer treatment. We offer a collaborative work environment, flexible locations, and opportunities for growth and development. If you're passionate about clinical operations and committed to delivering excellence, we encourage you to apply for this exciting opportunity.
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