Senior Manager, Local Study Operations

Role Overview

• Lead the skill development of Local Study Operations Senior Managers, ensuring the effective implementation of trials within the country and alignment with global strategies
• Oversee the delivery of the country’s study portfolio—including scope, timelines, and budgets—through the management of LSOM Senior Managers
• Collaborate with the Country GSSO Head to foster, enhance, and sustain an optimal clinical research environment that supports global R&D objectives
• Promote alignment and continuous improvement in LSOM execution by integrating best practices, digital innovations, and facilitating knowledge sharing among team members
• Ensure the successful delivery of the study portfolio assigned to LSOMs
• Oversee LSOMs’ fulfillment of responsibilities throughout the assigned country portfolio, from feasibility through to study close-out
• Monitor portfolio progress, provide risk and quality oversight, and support issue escalation and resolution for LSOMs
• Manage LSOM and LSOM vendor performance to guarantee high-quality study execution, serving as the primary escalation point for local study challenges, driving solutions, and ensuring portfolio targets are met within the country
• Mentor, train, and support the professional development of LSOMs to prepare them for managing complex trials
• Build and maintain a high-performing team
• Facilitate close collaboration between the study strategy team and local study teams to effectively manage the assigned portfolio
• Promote cross-functional collaboration among country teams to ensure successful delivery of the country portfolio
• Support discussions regarding study placement decisions based on country capabilities and growth potential
• Proactively evaluate risks, quality trends, and resource requirements; implement mitigation strategies and drive continuous improvement in country operations
• Lead initiatives to enhance operational efficiency and encourage sharing of best practices
• Manage resource allocation and workload distribution across LSOMs, including both FSP and FTE personnel, to optimize trial execution and align with global priorities
• Ensure adherence to regulatory and quality standards where applicable
• Collaborate with and support the country head in engaging cross-functional stakeholders, aligning on trial deliverables, and managing escalations

Requirements

• Doctorate degree & 2 years of clinical execution experience OR Master’s degree & 6 years of clinical execution experience OR Bachelor’s degree & 8 years of clinical execution experience OR Associate’s degree & 10 years of clinical execution experience OR High school diploma / GED & 12 years of clinical execution experience
• Minimum of 2 years’ experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources
• 7 years work experience in life sciences or medically related field, including 4 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
• Experience managing multiple teams / direct reports across multiple clinical functions / trials
• Experience at, or oversight of, clinical research vendors (CROs, central labs, imaging vendors, etc.)
• Experience managing clinical operations across relevant geography / region, including strong understanding of local regulatory requirements around global clinical trials

Benefits

• Flexible work arrangements
• Professional development