Study Delivery Resource Management Senior Manager Job at Amgen (Uxbridge)

Senior Manager, Study Delivery Resource Management (SDRM)

In this vital role, you will provide strategic oversight for resource planning a...

Location

United States

Salary:

170076.00 - 196130.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 2 years of clinical execution experience
Master’s degree and 6 years of clinical execution experience
Bachelor’s degree and 8 years of clinical execution experience
Associate’s degree and 10 years of clinical execution experience
High school diploma / GED and 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

Provide strategic oversight for resource planning and allocation across global clinical programs and countries
Lead the development of accurate, forward-looking resource forecasts & hiring plans
Analyze historical and real-time data to identify trends, anticipate capacity gaps, and identify opportunities & mitigations
Serve as the single point of accountability for ensuring consistent, equitable, and strategically aligned resource allocation decisions
Develop, own and oversee hiring plans in partnership with HR and GDO SPOs
Provide leadership oversight for the FSP engagement model
Act as the trusted liaison to functional leadership, program partners, and country resource points of contact
Lead cross-functional process improvement initiatives

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

Fulltime

Study Delivery Senior Manager

In this vital role, you will own global clinical trial delivery, translating pro...

Location

United Kingdom , Cambridge; London; Uxbridge

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Degree educated
Clinical trial execution experience and previous people leadership managing teams, projects, resources or directing the allocation of resources
Previous experience in life sciences or a related field, including biopharmaceutical clinical research
Previous management experience of direct reports across multiple geographies
Experience representing a sponsor company in regulatory audit/inspections
Experience at or oversight of outside clinical research vendors (CRO’s, central labs, imaging vendors, etc.)

Job Responsibility

Leading cross-functional study teams to deliver clinical data aligned with evidence generation strategy
Defining and executing study plans covering feasibility, site selection, site engagement, recruitment, retention, and vendor delivery
Identifying and managing study risks using quality-by-design and risk-based approaches to protect participant safety and data integrity
Overseeing global study execution, including enrollment, data flow, monitoring, and corrective actions
Providing clear leadership, issue resolution, and escalation management across geographies
Partnering effectively with internal stakeholders and external vendors to ensure performance and collaboration
Driving continuous improvement, innovation, and regulatory compliance throughout the study lifecycle

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

Senior Manager – Delivery Services

Completely manage a client account ensuring the right balance between delivery o...

Location

India , Kochi;Trivandrum

Salary:

Not provided

Experion Technologies

Expiration Date

Until further notice

Requirements

Completely manage a client account ensuring the right balance between delivery of ongoing projects and skills to maintain the customer relationship to identify new prospective projects from the client account
Experience and confidence in client management with good articulation, detailing and negotiation skills
Capable in coordinating client interactions for product requirement grooming and detailing, product development with modern engineering practices, user acceptance testing, rollout and release phases
Experience in Product Development in Web/Mobile technologies with industry standard engineering practices (CI/CD, DevOps, Automated Testing, Unit Testing through Code, Automated Review Gates etc.)
Passionate about going into functional and technical details along with inspiring, participating and motivating the core team in design/solutioning phases. Confidence to collect required details and present the same to client stakeholders
Expertise in handling end-to-end project delivery in Agile Methodology with hands on experience in Product Grooming, Agile Ceremonies, Collaborating with Technical Architects, Development, Testing, Release and Maintenance of the product
Excellent Project Management skills including Estimation, Scheduling, Tracking, Commercials and Quality
Experience in managing teams of size > 20 in a global delivery model
Experience in leading Agile teams anchoring different ceremonies like grooming, sprint planning, sprint retro and sprint demo
Excellent team management skills, enabling each team member to improve their competencies and work quality, and become better professionals

Local Study Operations, Senior Manager

Location

Australia , Sydney

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

Lead the skill development of Local Study Operation Managers (LSOM's), 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
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
Facilitate close collaboration between the study strategy team and local study teams to effectively manage the assigned portfolio

What we offer

health, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities

Fulltime

Senior Manager, Biostatistical Programming

Amgen is expanding its Global Statistical Programming (GSP) capabilities, with A...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

BA/BSc or higher degree in biostatistics, statistics, mathematics, computer science, or other related quantitative or scientific subjects, with at least 8 years of statistical programming experience in clinical development environment
Strong technical, communication, and leadership skills
Ability to lead and manage programmers in successful and timely completion of all programming activities for a study or multiple studies from end to end
Experience developing a successful offshore statistical programming team
Flexibility and desire to work across different time-zones
Advanced analysis and reporting skills in SAS (including SAS/STAT, Macro, Graph, SQL, etc.)
Prior regulatory submission experience for drug approval
Thorough understanding and experience with data quality and compliance checks
Experience in software development (e.g., gathering user requirements, creating technical specifications, developing code, creating, and driving test plans)
Experience working effectively in a globally dispersed team environment with cross-cultural partners

Job Responsibility

Accountable and responsible for ensuring successful execution and delivery of Global Statistical Programming milestone analysis deliverables and regulatory submission packages for a product, or group of Amgen products, being supported by the offshore programming team
Work with GPL to ensure successful implementation of programming strategies, such as functional standards and industry requirements for the assigned product globally
Plan and monitor progress of projects and address issues accordingly
Provide GSP product level input to developing and managing resource plans and budgets for GSP
Efficiently and effectively monitor and utilize assigned staff at product level according to priorities
Lead and/or participate in departmental process improvement initiatives and cross-functional working groups
Assist in study and system audits and inspections by internal and external bodies
Develop, review, and implement Policies, SOPs and other controlled documents affecting GSP globally
Provide hands-on support to the assigned product areas as required
Provide coaching and mentoring to local programming staff

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

Senior Manager, Biostatistical Programming

Amgen is expanding its Global Statistical Programming (GSP) capabilities, with A...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

BA/BSc or higher degree in biostatistics, statistics, mathematics, computer science, or other related quantitative or scientific subjects, with at least 8 years of statistical programming experience in clinical development environment
Strong technical, communication, and leadership skills
Ability to lead and manage programmers in successful and timely completion of all programming activities for a study or multiple studies from end to end
Experience developing a successful offshore statistical programming team
Flexibility and desire to work across different time-zones
Advanced analysis and reporting skills in SAS (including SAS/STAT, Macro, Graph, SQL, etc.)
Prior regulatory submission experience for drug approval
Thorough understanding and experience with data quality and compliance checks
Experience in software development (e.g., gathering user requirements, creating technical specifications, developing code, creating, and driving test plans)
Experience working effectively in a globally dispersed team environment with cross-cultural partners

Job Responsibility

Accountable and responsible for ensuring successful execution and delivery of Global Statistical Programming milestone analysis deliverables and regulatory submission packages for a product, or group of Amgen products, being supported by the offshore programming team
Work with GPL to ensure successful implementation of programming strategies, such as functional standards and industry requirements for the assigned product globally
Plan and monitor progress of projects and address issues accordingly
Provide GSP product level input to developing and managing resource plans and budgets for GSP
Efficiently and effectively monitor and utilize assigned staff at product level according to priorities
Lead and/or participate in departmental process improvement initiatives and cross-functional working groups
Assist in study and system audits and inspections by internal and external bodies
Develop, review, and implement Policies, SOPs and other controlled documents affecting GSP globally
Provide hands-on support to the assigned product areas as required
Provide coaching and mentoring to local programming staff

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

Biostatistical Programming Senior Manager

In this vital role you will provide operational and technical leadership for Rea...

Location

United Kingdom , Uxbridge; Cambridge

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Degree educated
Relevant statistical programming experience within life sciences, clinical development, or observational research
Experience leading people, projects, programs, or resource allocation activities within a programming environment
Experience working with real-world healthcare data, including healthcare claims and EHR databases
Strong programming expertise in SAS and SQL
Knowledge of observational research methods, drug development, and epidemiology principles
Strong communication, collaboration, and stakeholder management skills
Demonstrated leadership, problem-solving ability, innovation, and attention to detail
Experience with R and/or Python is preferred but not mandatory

Job Responsibility

Provide operational and technical leadership for Real-World Evidence (RWE) biostatistical programming within the Centre for Observational Research (CfOR)
Lead and develop programming teams, partnering closely with epidemiologists and cross-functional stakeholders across multiple time zones to deliver high-quality RWE from large healthcare data sources, including electronic health records (EHR) and healthcare claims databases
Oversee project delivery, resource planning, technical excellence, and compliance with departmental standards and processes to support regulatory, publication, and enterprise objectives
Leading and developing programming staff, including mentoring, workload planning, and performance oversight
Partnering with epidemiologists, RWE scientists, and programming leads to generate robust real-world evidence from healthcare data assets
Providing technical leadership and guidance in statistical programming methods, standards, and best practices
Managing programming activities, timelines, deliverables, and resource allocation across multiple projects and priorities
Ensuring programming activities comply with departmental standards, SOPs, quality expectations, and regulatory requirements
Authoring, reviewing, and approving programming plans, analysis dataset specifications, macros, and other key study documentation
Contributing to the development, validation, and execution of analysis datasets and outputs supporting regulatory submissions, publications, and scientific communications

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

Logistics Manager, Senior

Astrion, LLC has an exciting opportunity for a Logistics Manager, Senior located...

Location

United States , Dayton

Salary:

Not provided

Astrion

Expiration Date

Until further notice

Requirements

Background as a Technical Order Management Agent
Requires prior experience with Technical Order Management Agency (TOMA)
Experience with S1000
Advanced Degree (Master of Arts (MA)/Master of Science (MS)) and 12 years of experience in the respective technical/professional discipline being performed, 5 years of which must be in the DoD. OR, BA/BS degree, and 15 years of experience in the respective technical/professional discipline being performed, 5 of which must be in the DoD. OR, 20 years of directly related experience with proper certifications as described in the Functionally Aligned Job Descriptions, 8 of which must be in the DoD
Have a general understanding of current DoD and AF-specific acquisition regulations, guidelines, and processes
Have knowledge of the SORA Process and the broad range of factors that impact source of repair decisions in support of the USG
Have knowledge in software development and depot avionics testing and repair

Job Responsibility

Apply knowledge and experience in acquisition logistics philosophy, policies and procedures to USAF systems, subsystems, and equipment procurement activities, post award project/program management tasks, and acquisition programs throughout their life cycles
Support the coordination of all logistics elements to ensure all integrated logistics support requirements for the program are identified and tailored to the F-15 Division's needs
Obtain required logistics resources and participate in site surveys
Perform analyses of sustainment or related Diminishing Manufacturing Sources and Material Shortages issues and recommend suitable replacements
Identify and support SORA requirements and actions
Compile, and work to completion, the depot maintenance interservice study
Provide support to accomplish the generation and review of logistics support documentation
Participate in integrated logistics support management team meetings, Program Management Reviews, and other related meetings
Assist the Government in performing Logistics Support Analysis tasks
Provide support utilizing the Parts and Repair Ordering System and the Federal Logistics Data system

What we offer

Competitive salaries
Continuing education assistance
Professional development
Multiple healthcare benefits package options
401K with employer matching
Competitive time off policy along with a federally recognized holiday schedule

Fulltime

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Study Delivery Resource Management Senior Manager

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