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Position Summary:

Key Responsibilities

• Lead operational planning and execution of assigned clinical studies, ensuring alignment with development timelines and program objectives.
• Coordinate with cross-functional team to support study from start-up, site activation, patient enrollment through database lock and study closure.
• Oversight of clinical sites and CRAs for monitoring study progress and proactively address operational risks and challenges. Conduct co-monitoring visits as required to support sites and oversee CRAs.
• Contribute to the development and review of clinical documents such as study protocols and amendments, case report forms, informed consent forms, study manuals and plans.
• Proactive assessment of risks and development of mitigation strategies to meet study objectives, timelines and quality
• Support the development and oversight of study budgets in partnership with Clinical Operations leadership. Oversee accruals reporting and forecasting for assigned trials. Review site and vendor invoices for accuracy.
• Lead inspection readiness activities including proactive risk assessments, inspection preparation strategy and serving as an operational lead during regulatory inspections
• For outsourced studies, oversee the CRO and provide timely input to ensure that the study is executed according to the agreed project plan.  Responsible for management of CRO(s) performance to ensure adherence to scope of work within timelines and budget.
• May manage direct reports, including ongoing performance management, mentorship, and career development.
• Drives continuous improvement initiatives by identifying gaps in operational processes, contributing to SOP development, and implementing best practices to enhance quality, efficiency, and consistency across studies

Qualifications

• Bachelor’s degree in a scientific, medical, or healthcare-related discipline required; advanced degree preferred.
• Approximately 8+ years of experience demonstrating progression in clinical trial operations
• At least 2-3 years of recent experience managing complex late phase oncology clinical trials
• Experience in participation in regulatory inspections preferred
• Experience overseeing CROs and external vendors supporting clinical trial execution.
• Ability to engage in critical hands‑on activities to resolve complex issues or de‑risk execution, while maintaining primary accountability for study oversight and delivery
• Strong understanding of ICH-GCP guidelines and regulatory requirements governing clinical research.
• Strong organizational skills with the ability to manage multiple priorities in a fast-paced environment.
• Excellent written and verbal communication skills.
• Experience mentoring or guiding junior team members preferred.
• Ability to travel is required (~20%) Domestic travel only

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