Local Study Operations Line Manager Job at Amgen (Budapest)

Local Study Operations Line Manager

At Amgen, we are relentless in applying the highest ethical standards to our pro...

Location

Romania , Bucharest

Salary:

Not provided

Amgen

Expiration Date

Until further notice

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
minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources

Job Responsibility

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

What we offer

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible

Local Study Operations Line Manager

Location

South Korea , Seoul

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree & 2 years of clinical execution experience
Master’s degree & 6 years of clinical execution experience
Bachelor’s degree & 8 years of clinical execution experience
Associate’s degree & 10 years of clinical execution experience
High school diploma / GED & 12 years of clinical execution experience
minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources

Job Responsibility

Lead the skill development of Local Study Operations Managers
Ensure effective trial implementation within the country and strong alignment with global strategies
Oversee the delivery of the country’s study portfolio—managing scope, timelines, and budgets—through the leadership of LSOM
Foster, enhance, and sustain an optimal clinical research environment that supports global R&D objectives
Drive alignment and continuous improvement in LSOM execution by integrating best practices, promoting digital innovation, and facilitating robust knowledge sharing across the team
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
Mentor, train, and support the professional development of LSOMs

What we offer

Comprehensive employee benefits package
Retirement and Savings Plan with generous company contributions
Group medical, dental and vision coverage
Life and disability insurance
Flexible spending accounts
Discretionary annual bonus program
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible

Fulltime

Local Study Operations Line Manager

Location

Hungary , Budapest

Salary:

Not provided

Amgen

Expiration Date

Until further notice

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
2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources

Job Responsibility

Lead the skill development of Local Study Operations Managers, ensuring effective trial implementation within the country and strong alignment with global strategies
Oversee the delivery of the country's study portfolio—managing scope, timelines, and budgets—through the leadership of LSOM
Work in close partnership with the Country GSSO Head to help foster, enhance, and sustain an optimal clinical research environment that supports global R&D objectives
Drive alignment and continuous improvement in LSOM execution by integrating best practices, promoting digital innovation, and facilitating robust knowledge sharing across the team
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

What we offer

Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development

Fulltime

LSOM Line Manager (Local Study Operations Line Manager)

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part...

Location

Taiwan , Taipei

Salary:

Not provided

Amgen

Expiration Date

Until further notice

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.

Job Responsibility

Lead the skill development of Local Study Operations Managers, ensuring effective trial implementation within the country and strong alignment with global strategies
Oversee the delivery of the country’s study portfolio—managing scope, timelines, and budgets—through the leadership of LSOM
Working in close partnership with the Country GSSO Head, help foster, enhance, and sustain an optimal clinical research environment that supports global R&D objectives
Drive alignment and continuous improvement in LSOM execution by integrating best practices, promoting digital innovation, and facilitating robust knowledge sharing across the team
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

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Fulltime

Us Country Head, Global Site & Study Operations Senior Director

Provide strategic and operational leadership for all study and site execution wi...

Location

United States

Salary:

228624.00 - 265674.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree & 5 years of clinical execution experience or equivalent
Master's degree & 9 years of clinical execution experience or equivalent
Bachelor's degree & 11 years of clinical execution experience or equivalent
In addition to meeting at least one of the above requirements, you must have a minimum of 5 years' experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources.

Job Responsibility

Provide strategic and operational leadership for all study and site execution within the assigned country or hub-and-spoke geography, ensuring delivery of the clinical portfolio in alignment with global study strategies, regulatory requirements, and Amgen quality standards
Accountable for end-to-end study, site, and site engagement execution across the assigned country or hub-and-spoke geography, delivering start-up, enrolment, retention, data quality, and patient safety outcomes in compliance with local regulations and global strategies
Provide strategic leadership for country commitments, acting as a key advisor on study feasibility, placement, and site selection, aligned to global portfolio priorities and regional strengths
Lead, line-manage, and develop the Country/Hub team, ensuring clear direction, strong performance, capability development, and succession planning to deliver portfolio and organizational objectives
Ensure adequate and timely resourcing across study delivery, site operations, and monitoring roles, working closely with global partners to match capacity and capability to portfolio demand
Drive site engagement through a clearly differentiated Amgen site experience strengthening investigator and site relationships through strong leadership, compliance, innovation, and collaboration with global study teams
Oversee country-level financial and operational management, including budgets, forecasting, vendor oversight, and efficient allocation of resources to ensure accountability and value delivery
Lead country governance and risk management, including chairing the Country Management Team (CMT),representing the country in senior governance forums, and managing risks, issues, and escalation to protect quality and delivery
Ensure regulatory compliance, inspection readiness, and continuous improvement, promoting best-practice sharing, audit readiness, and adherence to ICH-GCP, SOPs, and local regulatory requirements.

What we offer

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible

Study Manager

Study Manager. ICON plc is a world-leading healthcare intelligence and clinical ...

Location

Poland , Warsaw

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

University degree (or equivalent), preferably in life sciences, medical sciences, or a related clinical research discipline
Minimum of 3+ years’ experience within a pharmaceutical, biotech, or clinical research environment
Strong understanding of clinical trials and the drug development lifecycle
Thorough knowledge of ICH‑GCP, regulatory requirements, and clinical study delivery best practices
Experience working with industry‑standard clinical systems, including Trial Master File (TMF / eTMF)
Demonstrated project management capability, with strong organisational, analytical, and financial awareness
Excellent written and verbal communication skills in English
Proven ability to build effective relationships and manage external service providers

Job Responsibility

Partner closely with the Study Delivery Lead to support end-to-end operational delivery of clinical studies, from start-up through close-out and archiving
Establish, maintain, and oversee study plans, internal systems, databases, trackers, and project documentation to support effective study execution
Collaborate cross‑functionally with internal teams and external partners, including CROs and vendors, to manage study operations across all phases and therapeutic areas in line with applicable regulations, operating models, and industry standards
Monitor study progress, proactively identify risks or issues, and escalate or resolve challenges impacting quality, timelines, or budget
Review and contribute to key clinical documents such as protocols, informed consent forms, and operational plans (e.g. Monitoring Plans, Risk Management Plans, Vendor Oversight Plans, Communication Plans)
Lead and facilitate interactions with internal stakeholders (e.g. regulatory, quality, local country teams) and external vendors to ensure aligned and effective study delivery
Provide oversight of CROs and third‑party suppliers, acting as a primary point of contact and ensuring delivery of contracted services to agreed timelines and quality standards
Oversee country‑level study activities, including recruitment progress, data quality, regulatory approvals, protocol deviations, and compliance tracking

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Fulltime

Clinical Laboratory Study Manager

Location

United States

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Minimum of 6 years clinical research experience with academic, Contract Research Organization, pharmaceutical or biotech industry
Working knowledge of clinical drug development process and clinical databases, as well as ICH, GCP guidelines, and US FDA and/or local country regulations as applicable
Requires bachelor degree in life sciences or equivalent (i.e., science, technology, engineering, or mathematics) or relevant work experience. Biology or equivalent major preferred.
Strong project management and organization skills in a matrix environment
Analytical and problem-solving experience
Excellent written and verbal communication skills
Effective communication and interpersonal skills, with proven ability to build relationships internally and externally
Fluent in speaking/writing English
Proficiency in Microsoft Office applications, including strong excel knowledge, as well as relevant role specific systems
Proficiency in Python, R, Perl, SQL or other programming languages, as well as familiarity with APIs and Linux/Unix environments, if acting as programming lead for supplies and laboratory operations

Job Responsibility

Participates in cross-functional study team meetings and workstreams to support the delivery of the precision medicine strategy for the assigned studies
Supports clinical study teams as subject-matter expert for technical and operational matters related to sample management and testing, including anticipating challenges, managing risk across projects and responding queries from internal and external stakeholders
Works with clinical study teams on the development and review of sample-related sections of study-specific documents such as the clinical protocol, Informed Consent Forms (ICFs) and sample management guidelines
Supports project management and study set-up teams in the creation and validation of specialty laboratory databases for data collection and sample kit tracking
Manages all activities related to biosample process planning and execution, including storage, shipping, and data transfer throughout the study lifecycle
Oversees the acquisition and testing of clinical trial samples designated for biomarker research (including human tissue, whole blood, plasma, serum, etc.), liaising with relevant stakeholders to assess biosample vendors, review proposals/bids, and define contractual scope
Forecasts operational costs and timelines, and manages budgeting, invoicing and reporting for study-related operations
Works closely with data management and biostatistics leads to determine how biomarker data will be captured, blinded, transferred and reported for clinical trials
Develops and reviews data transfer specifications and related documents
Provides guidance and training to clinical teams and investigative sites regarding collection, storage and shipment of biospecimens to ensure compliance with the clinical protocol

Port Operations Manager

Join our team as a Port Operations Manager where you will be responsible for ove...

Location

Greece , Piraeus

Salary:

Not provided

TUI

Expiration Date

Until further notice

Requirements

Excellent communication skills in English (both written and verbal)
Educational background: A good academic background is required
maritime studies or related qualifications are highly desirable
Experience: 3+ years of experience as a Port Agent or Supervisor in port operations
Skills: Strong analytical and problem-solving abilities with a solution-oriented mindset
Excellent communication, innovation, and adaptability skills are essential
Multitasking: Ability to manage multiple tasks simultaneously, with a strong focus on prioritization and time management
Organizational skills: Strong office administration and organizational skills, with attention to detail
Technical proficiency: Proficient in Microsoft Office programs (Word, Excel, PowerPoint, etc.) and other relevant software tools
Time management: Ability to manage time effectively, especially when working across different time zones

Job Responsibility

Oversee and manage all operational requirements related to vessel calls, ensuring smooth and efficient port operations
Responsible for monitoring the day-to-day operations at the port to ensure the team adheres to port policies, governing laws, procedures, and best practices
Responsible of interacting, creating, and maintaining strong relationships with clients, vendors, government officials and port/terminal authorities to ensure operational success
Provide leadership, guidance, and mentorship to port agents, ensuring they meet performance standards and adhere to operational requirements
Coordinate and liaise with all vendors to ensure that the equipment and services provided meets the expectations of Intercruises and its clients
Ensure all respective sailing documents are completed within a timely manner to ensure invoicing/billing is on track
Actively participate in conference calls with vessels and or cruise lines when needed
Responsible for the creation of port agent schedule to ensure coverage
Assign tasks, delegate responsibilities, and manage workload distribution to optimize efficiency and productivity
Independently oversee reporting agent’s team, responsible for training, performance evaluations and recruitment/selection in collaboration with Human Resources

What we offer

Attractive remuneration
discretionary bonus schemes
generous travel benefits
extensive health & well-being support
Flexible working
Access the TUI Learning Hub
opportunities to work on global projects and teams
Get involved with incredible local charity and sustainability initiatives like the TUI Care Foundation

Fulltime

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Local Study Operations Line Manager

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