Career CategoryClinical DevelopmentJob DescriptionLOCAL STUDY OPERATIONS SENIOR MANAGERResponsibilities• 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 supplier 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.QualificationsMinimum 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• In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced abovePreferred Requirements (based of GTM)• 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 suppliers (CRO’s, central labs, imaging suppliers, etc.)• Experience managing clinical operations across relevant geography / region, including strong understanding of local regulatory requirements around global clinical trialsCompetencies• Skilled in developing site-specific operational plans that enhance efficiency, compliance, and patient safety while implementing best practices and continuous improvement methodologies• Proficient in ensuring site preparedness and smooth execution across all study phases by supporting site initiation visits (SIVs), recruitment calls, and adherence to study timelines• Clear understanding of country level regulations and compliance for clinical trials, keeping up to date on clinical trial that may impacting managing ethics submissions, study start-up processes, and site inspection readiness at a country-level• Experience with developing and training teams related to clinical trial materials (e.g., CRAs, site staff, and cross-functional teams) to ensure alignment with study protocols, regulatory requirements, and best practices• Ability to identify operational risks based on protocol design and implement innovative mitigation strategies. Identify and manage study issues, communicating and/or escalating appropriately.• Demonstrates ability for end-to-end management of study deliverables, budgets, timelines, and performance metrics (KPIs) to optimize trial execution.• Experience with overseeing study budgets and financial operations, reviewing/approving site expenditures, and optimizing resource allocation to ensure cost efficiencies• Strong collaboration and communication skills to engage with cross-functional teams, senior management and external stakeholders, internally and externally• Able to identify and implement opportunities for continuous improvement into the team’s working practices• Navigates diverse regulatory, cultural, and operational environments. Builds strong relationships across geographies and time zones.• Ability to manage, mentor, and develop professionals and support staff across functions, while fostering collaboration across internal and external teams for trial success.