Local Study Operations Senior Manager

Amgen SA; Fatih; On-site; TRY 700,000 - 1,000,000; Full time

Job summary

Amgen SA in Turkey seeks a Local Study Operations Senior Manager to deliver the study portfolio across the country, from feasibility through close-out, overseeing LSOMs and suppliers.

You will mentor teams, drive cross-functional collaboration, manage budgets and timelines, and ensure regulatory and quality standards are met while improving operational efficiency.

Qualifications

• Doctorate degree with 2 years of leadership experience.
• Master’s degree with 6 years of clinical execution experience.
• Bachelor’s degree with 8 years of clinical execution experience.
• Associate’s degree with 10 years of clinical execution experience.
• High school diploma / GED with 12 years of clinical execution experience.
• 2 years of people leadership/management experience required.

Responsibilities

• Deliver the study portfolio assigned to LSOMs.
• Oversee LSOMs’ country portfolio from feasibility to close-out.
• Monitor portfolio progress, risk and quality oversight; escalate issues.
• Manage LSOM and LSOM supplier performance for high-quality execution.
• Mentor, train, and develop LSOMs for complex trials.
• Build and maintain a high-performing team.
• Facilitate cross-functional collaboration between study strategy and local teams.
• Promote cross-country collaboration to ensure delivery of the country portfolio.
• Support study placement discussions based on country capabilities and growth potential.
• Evaluate risks, quality trends, and resources; implement mitigations and drive improvements.
• Lead initiatives to enhance operational efficiency and share best practices.
• Allocate resources across LSOMs (FSP and FTE) to align with priorities.
• Ensure adherence to regulatory and quality standards.

Skills

Leadership

Risk management

Cross-functional collaboration

Regulatory compliance

Team mentoring

Budget management

Stakeholder communication

Global operations

Operational planning

Quality oversight

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma / GED

Tools

CROs

Central labs

Job description

LOCAL STUDY OPERATIONS SENIOR MANAGER

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.

Qualifications

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