Description
**Accountabilities**
+ 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.
**Responsibilities**
+ 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.
**Minimum 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 of resources. Your managerial experience may run concurrently with the required technical experience referenced above.
**Preferred Requirements (based on 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 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
**Competencies**
+ 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
