Job Description:
• Lead the strategic planning and execution of study start-up activities across clinical programs, ensuring rapid, high-quality site activation.
• Provide leadership to cross-functional teams, oversee budgets, engage key stakeholders, and drive continuous process improvements.
• Develop and implement activation strategies, manage regulatory and ethics submissions (IRB/EC and Health Authorities), oversee site contract and budget negotiations.
• Monitor operational KPIs, ensure audit and inspection readiness, and lead end-to-end study start-up activities.
• Drive continuous improvement initiatives focused on reducing activation timelines and increasing predictability, and evaluate and introduce innovative tools.
• Champion change management related 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 track record of operational excellence in delivering clinical trials, ideally including innovative approaches to speed up study start-up and site activation.
• Extensive experience as a direct 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 oversight.
• Ability to work independently and manage multiple priorities effectively.
Benefits:
• Medical
• Dental
• Vision
• 401(k)
• FSA/HSA
• Life Insurance
• Paid Time Off
• Wellness
• Annual bonus plan
• Incentive compensation plan
• Employee Stock Purchase Plan