Senior Manager, Local Study Operations

Amgen Inc. (IR); Stockholms kommun; On-site; SEK 1,100,000 - 1,700,000; Full time

Job summary

Amgen Inc. (IR) is seeking a Senior Manager, Local Study Operations in Sweden to lead the Local Study Operations Managers, drive country study portfolio execution, and align with global strategies.

You will oversee study delivery, timelines, and budgets while fostering cross-functional collaboration and a culture of continuous improvement. The role emphasizes leadership, risk management, and site initiation support across multiple trials, ensuring regulatory compliance and optimal performance of

Qualifications

• Doctoral degree and 2+ years of clinical execution experience or an equivalent combination.
• Experience leading teams and managing resources across trials.

Responsibilities

• Lead LSOMs and oversee country study portfolio delivery within scope, timelines, and budgets.
• Mentor LSOMs and develop the team to manage complex trials.
• Ensure regulatory compliance and drive continuous process improvements.

Skills

Leadership

Budget management

Risk management

Cross-functional collaboration

Clinical trial operations

Mentoring

Site initiation visits

Process improvement

Education

Doctorate or equivalent in life sciences

Master's degree in a related field

Bachelor's degree in life sciences

Job description

## Senior Manager, Local Study OperationsApplyremote type: On Sitelocations: Sweden - Stockholmtime type: Full timeposted on: Posted Todayjob requisition id: R-249379## **Career Category**Clinical Development## ## **Job 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 oversightQualifications 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 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 successFor union related matters please contact: [e-mail]