Description
Accountabilities
• Lead the skill development of Local Study Operations 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-Hub Head GSSO 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 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.
Authority
• Supervision and direction of Local Study Operations Managers
• Line management responsibilities including performance assessments of LSOMs
• Management of FSP supplier resource distribution and assurance of high-quality service delivery.
Outputs
• A high-performing LSOM team
• Delivery of quality data within defined scope, timelines, and budget
• Effective resource allocation and workload management across LSOMs to support the country portfolio
• Management of FSP supplier resources and performance, including tracking metrics for quality oversight
Qualifications
Describe the knowledge and skills necessary to perform the duties of this role. Include a
combination of education, experience, knowledge, or the equivalent
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 or resources. Your managerial experience may
run concurrently with the required technical experience referenced above
Preferred 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 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
For union related matters please contact: unionen@amgen.com
