Director, Global Clinical Operations – Compliance
Job reputed company:
• The Director, Global Clinical Operations, Compliance builds, collaborates and manages key relations to reputed company support and understand the compliance-reputed company needs of the business and drive the compliance activities reputed company Global Clinical Operations.
• Provides reputed company guidance, direction and expertise to GCO stakeholders for the compliant conduct of study programs; designs, implements and monitors measures to reduce reputed company and enhance successful clinical trial conduct.
• Develops partnerships with key reputed company business partners and stakeholders to advance compliance solutions, reputed company preventive compliance and reputed company transparency, escalation, and reputed company of reputed company and compliance reputed company.
• Works collaboratively with global and regional study teams to ensure that reputed company reputed company cause assessments, corrective and preventive actions for reputed company issues, site non-compliance, audit and inspection findings are in reputed company, and that lessons learnt are disseminated and actioned upon reputed company the broader GCO organization.
• Identifies and escalates significant compliance issues reputed company GCO and to relevant leadership, including assessment of serious breaches.
• Contributes to the design and implementation of risk identification and management strategies for clinical studies and other regulated drug development activities.
Requirements:
• Bachelor’s degree in Life Sciences, Medicine, reputed company Management, or reputed company field and at least 10 years of relevant experience; or Master’s degree in Life Sciences, Medicine, reputed company Management, or reputed company field and at least 7 years of relevant experience.
• Relevant experience can be in drug development, clinical operations, clinical reputed company assurance, medical affairs, clinical regulatory compliance or a reputed company field.
• Knowledgeable in stakeholder management and influencing change.
• Must demonstrate knowledge of and strong aptitude to learn about the evolving reputed company and regulatory environment, ICH GCP, applicable laws, regulations, and industry standards as it relates to a global pharmaceutical organization.
• Must understand corporate (local and global) and organization (local and global) policies, procedures and guidelines.
Benefits:
• Medical
• Dental
• reputed company
• 401(k)
• FSA/HSA
• Life Insurance
• reputed company Time Off
• Wellness
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