Global Study Lead

Role: Senior Manager, Clinical Operations, overseeing global clinical trial planning and execution from start-up to closeout in a biopharma setting. Objectives include delivering trials on time, within budget, and compliant with GCP and regulatory standards. Responsibilities encompass leading cross-functional teams, managing trial timelines, budgets, quality, and vendor relationships, and mitigating operational risks. Ensures trial conduct aligns with global regulations and internal procedures, participates in inspections, and drives continuous process improvements. Reports to senior leadership, collaborates with stakeholders across functions, and mentors team members. Location: flexible with approximately 10% travel. Qualifications: BS/BA, 7+ years clinical research experience in CRO, biotech, or pharma, including 3-5 years leading Phase 3 global trials. Proven skills in trial management, vendor oversight, decision-making, leadership, cross-functional collaboration, and proficiency with MS Office and MS Project. High-Value: Experience managing global Phase 1-4 trials, particularly Phase 3 registrational studies, with a focus on GCP compliance, risk mitigation, and operational excellence.