Study Start-up Manager Job at Amgen (Cambridge)

Study Start-up Manager

Drive the planning and execution of clinical study start-up activities, ensuring...

Location

United States

Salary:

122229.00 - 150449.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Pharma and clinical trial processes and operations expertise
Experience leading and managing global teams
Project management experience
Experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources
Doctorate degree OR Master’s degree and 3 years of clinical execution experience OR Bachelor’s degree and 5 years of clinical execution experience OR Associate’s degree and 10 years of clinical execution experience OR High school diploma / GED and 12 years of clinical execution experience

Job Responsibility

Lead the planning and delivery of clinical study start-up activities from global to local, ensuring timelines, quality, budget, and regulatory compliance are met
Own and manage study start-up plans and milestones, maintaining oversight of progress and resolving issues to keep delivery on track
Act as the primary point of contact for cross-functional start-up teams, driving clarity of roles, accountability, and collaboration
Identify, assess, and mitigate risks proactively, contributing to study risk assessments and ensuring timely study start
Partner closely with Study Delivery Leads, managers, and local teams, providing clear updates, solutions, and escalation where needed
Apply strong operational and regulatory knowledge (e.g. ICH-GCP, submissions and start-up processes) to enable high-quality execution
Manage internal resources and external suppliers to ensure efficient and compliant delivery of start-up activities
Contribute to continuous improvement by sharing expertise, mentoring colleagues, and developing best practices within the SSU hub

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 Start-up Manager-South Korea-ICON Strategic Solutions

As a Clinical Trial Manager at ICON, you will manage clinical trial operations a...

Location

South Korea , Seoul

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

University degree in medicine, science, or equivalent combination of education & experience
Demonstrated ability to drive the clinical deliverables of a study
Subject matter expertise in the designated therapeutic area
Prior monitoring experience is preferred
Willingness to travel as required (approximately 25%)

Job Responsibility

Manage clinical trial operations activities
Plan, execute and report from country feasibility up to and including site initiation for assigned innovative medicines phase I-IV studies
Act as single point of contact and local study team lead within the country/cluster
Support study feasibility and country patient commitments
Lead site selection
Ensure study start-up activities are conducted and completed on time
Oversee local vendor selection and performance
Drive the conduct of the study and track status
Ensure recruitment targets are met
Oversee local clinical team activities

What we offer

Various annual leave entitlements
A range of health insurance offerings
Competitive retirement planning offerings
Global Employee Assistance Programme
Life assurance
Flexible country-specific optional benefits including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments

Fulltime

Manager, Study Start Up

As a Manager, Study Start Up at ICON, you will lead and oversee the start-up act...

Location

United States , Blue Bell

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in a relevant scientific discipline or healthcare-related field
Extensive experience in clinical trial study start-up, with a strong understanding of global regulatory requirements and clinical operations
Proven leadership skills, with experience managing and mentoring teams in a fast-paced, deadline-driven environment
Excellent organizational and project management skills, with the ability to handle multiple studies and priorities simultaneously
Strong communication and stakeholder management skills, with the ability to collaborate effectively with sponsors and internal teams
Experience with process optimization and implementing best practices in study start-up activities
Willingness to travel as required (approximately 25%)

Job Responsibility

Managing and overseeing the end-to-end study start-up process, including site identification, feasibility, regulatory submissions, and site activation
Leading a team of study start-up professionals, providing guidance, mentorship, and support to ensure high performance and successful project delivery
Collaborating with sponsors, clinical operations, and regulatory teams to ensure compliance with local and global regulations and timelines for clinical trial initiation
Monitoring study start-up metrics, timelines, and budgets to ensure projects are delivered on time and within scope
Identifying potential risks and challenges in the start-up process and implementing strategies to mitigate delays or issues
Driving continuous improvement initiatives to optimize the study start-up process and enhance overall efficiency

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

Director study start-up

Ensure world-class study start-up planning and execution by leading teams, stren...

Location

United States

Salary:

206344.00 - 238674.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Pharma and clinical trial processes and operations expertise
Experience leading and managing global teams
Project management experience
Doctorate degree & 4 years of clinical execution experience or equivalent OR Master’s degree & 8 years of clinical execution experience or equivalent OR Bachelor’s degree & 10 years of clinical execution experience or equivalent
Minimum of 4 years' experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources

Job Responsibility

Lead and inspire the Study Start-Up Management team to deliver high-quality study start-up activities with speed, efficiency, and budget discipline
Provide strategic direction and people leadership to SSU Senior Managers
Drive continuous improvement through leadership of the SSU Hub
Oversee SSU operating model performance
Ensure strong SSU management capability through targeted development of skills, processes, systems, and technology expertise
Lead SSU manager resource planning and forecasting
Foster a culture of empowerment, collaboration, and open communication
Build strong partnerships with global and cross-functional stakeholders

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

Associate Director Study Start-up

Drive world-class study start-up planning and execution across a global portfoli...

Location

United States

Salary:

182145.00 - 212860.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Pharma and clinical trial processes and operations expertise
Experience leading and managing global teams
Project management experience
Minimum of 3 years' experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources
Must meet one of the following education/experience combinations: Doctorate degree and 3 years of clinical execution experience
Master’s degree and 7 years of clinical execution experience
Bachelor’s degree and 9 years of clinical execution experience
Associate’s degree and 12 years of clinical execution experience
High school diploma / GED and 14 years of clinical execution experience

Job Responsibility

Lead and manage a team of Study Start-up Managers
Drive end-to-end study start-up planning and execution from global to local
Provide portfolio-level oversight of study start-up performance, resourcing, and delivery metrics
Build team capability through coaching, mentoring, performance management
Partner with functional and hub leaders to strengthen study start-up capabilities
Own and embed study start-up business processes
Foster a collaborative, high-engagement culture
Contribute to the evolution of the Study Start-up Hub model

What we offer

Total Rewards Plan comprising health and welfare plans for staff and eligible dependents
Financial plans with opportunities to save towards retirement or other goals
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

Associate Director Study Start-Up

In this vital role you will lead world-class study start-up planning and executi...

Location

United Kingdom , Cambridge; London; Uxbridge

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Degree educated
Clinical trial execution experience and previous experience leading and managing global teams across multiple clinical functions as well as project management experience
Previous experience in life sciences focusing on clinical trials, including biopharmaceutical clinical research
Previous management experience of direct reports and/or global teams across multiple clinical functions

Job Responsibility

Lead and develop a team of Study Start-up Managers to deliver high-quality, compliant start-up activities across programs and therapeutic areas
Drive end-to-end global and local study start-up planning and execution, meeting timelines, budget, and regulatory (ICH-GCP) requirements
Provide portfolio-level oversight of performance, resourcing, and metrics, proactively identifying risks and recommending solutions
Build team capability through coaching, mentoring, and performance management, embedding best practices and continuous improvement
Partner with functional and hub leaders to strengthen start-up capabilities, processes, and operational readiness
Own and embed study start-up processes and contribute to the evolution of the Study Start-up Hub model, fostering collaboration, innovation, and knowledge sharing

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

Director Study Start-Up

In this vital role you will ensure world-class study start-up planning and execu...

Location

United Kingdom , Uxbridge; London; Cambridge

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Degree educated
Clinical trial execution experience
Previous experience leading and managing global teams across multiple clinical functions
Project management experience
Previous management experience of direct reports and/or global teams across multiple geographies
Experience working with or overseeing clinical research vendors (e.g., CROs, central labs, imaging)

Job Responsibility

Lead and inspire the Study Start-Up Management team to deliver high-quality study start-up activities with speed, efficiency, and budget discipline
Provide strategic direction and people leadership to SSU Senior Managers, building a high-performing, engaged, and future-ready team
Drive continuous improvement through leadership of the SSU Hub, promoting innovation, consistency, and best-practice ways of working
Oversee SSU operating model performance, proactively identifying risks and implementing improvements to optimise delivery outcomes
Ensure strong SSU management capability through targeted development of skills, processes, systems, and technology expertise
Lead SSU manager resource planning and forecasting to ensure optimal capacity and effective portfolio delivery
Foster a culture of empowerment, collaboration, and open communication that encourages learning and challenges the status quo

What we offer

Clear and disciplined strategic vision for the future that leverages superior-quality products, operational excellence and top-shelf-talent
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

Executive Director, Study Start-Up

In this vital role as Executive Director, Study Start-Up (SSU), you will lead SS...

Location

United States , Thousand Oaks

Salary:

281634.00 - 336501.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 6 years of clinical execution experience
Master’s degree and 10 years of clinical execution experience
Bachelor’s degree and 12 years of clinical execution experience
6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
12+ years’ work experience in life sciences industry, particularly focusing on clinical trial work, including 10+ years of biopharmaceutical clinical research experience obtained at a biotech or pharmaceutical company
Experience engaging and working across clinical trial teams in multiple geographies to deliver global clinical trials
Experience driving and leading organizations through cross-functional change initiatives such as identifying solutions to problems and innovating and change strategies and structure to meet future needs
Experience leading cross-functional / cross-geography / cross-trial teams, ensuring operational excellence and smooth decision-making
ability to escalate and resolve challenges in alignment with global study strategy priorities
Extensive knowledge of the clinical and pharmaceutical drug development process, from early to late-stage development with a deep understanding of relevant therapeutic areas to meet the highest scientific and regulatory standards

Job Responsibility

Shape the long-term vision and strategy of the SSU Hub, ensuring alignment with CPSO, GDO, and enterprise priorities
Integrate and harmonize strategies from the six sub-functions into a single global capability strategy, balancing standardization with local/regional adaptability
Act as the global escalation point for study start-up risks and issues, ensuring timely resolution and portfolio-level visibility
Embed within the industry - bringing outside ways of working and representing Amgen back into the industry
Build and develop a high-performing global SSU leadership team (Directors, Sr Managers) creating a culture of accountability, innovation and operational excellence
Lead, and mentor the global SSU Hub leadership team, ensuring robust succession planning, talent development, and organizational effectiveness
Drive consistent performance management, alignment, and calibration across sub-functions to ensure equitable resourcing and delivery
Embed a center of excellence mindset, encouraging knowledge-sharing and best practice adoption globally
Oversee start-up planning and execution across all new studies globally, ensuring timelines and quality standards are consistently achieved
Partner with Clinical Program Strategy and Operations TA Heads to ensure seamless integration of start-up into program execution

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

Select Country

Study Start-up Manager

Job Description

Job Responsibility

Requirements

What we offer

Looking for more opportunities?