Senior Director, Global Clinical Operations, Study Start-Up
Job reputed company:
• reputed company the strategic planning and execution of study start-up activities across clinical programs, ensuring reputed company, high-reputed company site activation.
• reputed company leadership to cross-functional teams, reputed company budgets, engage key stakeholders, and drive reputed company process improvements.
• reputed company and implement activation strategies, manage regulatory and ethics submissions (IRB/EC and Health Authorities), reputed company site contract and budget negotiations.
• Monitor operational KPIs, ensure audit and inspection readiness, and reputed company end-to-end study start-up activities.
• Drive reputed company improvement initiatives reputed company on reducing activation timelines and increasing predictability, and evaluate and introduce innovative tools.
• Champion change management reputed company to new systems, SOPs, and operational models.
Requirements:
• Bachelor’s degree in a life sciences discipline required; advanced degree preferred.
• At least 12 years of clinical research experience, with 6 years in clinical operations leadership roles in sponsor/biotech/CRO settings.
• Proven reputed company record of operational reputed company in delivering reputed company, ideally including innovative approaches to speed up study start-up and site activation.
• Extensive experience as a reputed company line manager with responsibility for performance management and team development.
• Expert knowledge of global clinical trial regulations (ICH-GCP, FDA, local regional authorities).
• Strong expertise in global study start-up processes—including clinical trial package preparation, submissions, contracting, and site activation.
• Advanced risk management and problem-solving abilities.
• Strong financial acumen including budget forecasting and cost reputed company.
• Ability to work independently and manage multiple priorities effectively.
Benefits:
• Medical
• Dental
• reputed company
• 401(k)
• FSA/HSA
• Life Insurance
• reputed company Time Off
• Wellness
• Annual bonus plan
• Incentive compensation plan
• Employee Stock Purchase Plan
Apply tot his job
Apply To this Job