Study Delivery Sr Mgr (Study Delivery Lead)

Role Summary

Own end-to-end global clinical trial delivery, translating product and clinical objectives into executable plans that enable timely, high-quality data. Lead cross-functional study teams and manage quality, timelines, budget, and operational performance across geographies. Identify and mitigate study risks to protect participant safety and data integrity, while driving continuous improvement and regulatory compliance throughout all phases of clinical trial delivery.

Responsibilities

• Lead and align cross-functional study teams to deliver high-quality clinical data in line with the evidence generation strategy.
• Define and implement study plans inclusive of feasibility, site selection, site engagement, recruitment and retention, and vendor delivery.
• Proactively identify and manage study risks, driving quality-by-design and risk-based approaches to ensure participant safety and data integrity.
• Oversee global study execution, including enrollment, data flow, monitoring, and corrective actions where needed.
• Provide clear leadership, direction, and escalation management to resolve complex study issues across geographies.
• Build strong partnerships with internal stakeholders and external vendors, ensuring effective collaboration and performance.
• Champion continuous improvement, innovation, and regulatory compliance across all phases of clinical trial delivery.

Qualifications

• Required: Doctorate degree and 2 years of Clinical Execution experience
• Required: Master’s degree and 4 years of Clinical Execution experience
• Required: Bachelor’s degree and 6 years of Clinical Execution experience
• Required: Associate’s degree and 10 years of Clinical Execution experience
• Required: High school diploma / GED and 12 years of Clinical Execution experience
• Preferred: 7 years’ work experience in life sciences or medically related field, including 5 years of biopharmaceutical clinical research experience obtained leading global clinical trials in a biotech, pharmaceutical or CRO company
• Preferred: Experience managing direct reports across multiple geographies
• Preferred: Experience representing a sponsor company in regulatory audit/inspections
• Preferred: Experience at or oversight of outside clinical research vendors (CROs, central labs, imaging vendors, etc.)