Study Start-up Manager Job at Amgen

New

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

New

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

New

Study Start-up Manager

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

Location

United Kingdom , Cambridge; Uxbridge

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Degree educated
Clinical trial execution experience
Previous experience leading people/teams and working in global teams across multiple geographies
Project management experience
Experience with risk-based monitoring models / risk-based quality management, and/or clinical site management
PMP Certification

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

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

Manager, Clinical Operations, International

Cabaletta is seeking a Manager/Sr Manager, Clinical Operations, International. R...

Location

Germany; Switzerland

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Bachelor’s Degree or advanced degree in life sciences or related field
Minimum 4 years of clinical trial management experience including management of study resources, vendors, budgets, supplies, critical path activities, and risk management, within Biotech or pharmaceutical industry or equivalent by experience
Cell therapy experience preferred and/or focus complex therapies
Fluency in English
working proficiency in additional European languages a plus
Experience with early phase, complex trials
Experience managing Contract Research Organizations and other external vendors
Good understanding of European regulatory requirements (EMA, MHRA, etc)
Working knowledge of GCP/ ICH regulatory guidelines
Extensive knowledge of standard industry practices related to study start-up, site management and monitoring, document management, and clinical supply management

Job Responsibility

Provide day-to-day clinical project management oversight of the full range of clinical operations activities associated with clinical trial conduct from protocol development, feasibility/capability assessments, initiation, execution, control, and closure
Perform hands-on activities not outsourced to vendors, as needed
Author study documents and plans such as ICF and study specific plans
Provide input and review of site training materials
Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate
Proactively identify risks and lead team members to mitigate risks in a timely fashion
Develop and maintain positive relationships, both internal and external to project, including site personnel (KOLs, PIs, Study Coordinators)
Select and manage vendors
Perform and document study-level Sponsor Oversight of outsourced clinical activities
Execute clinical operations country submission tasks and documents: Review submission pack, coordinate country-specific ethics RFIs, review and update site-specific consent forms

What we offer

health and retirement
PTO
stock option plans

Senior Clinical Trial Manager

The Sr. Clinical Trial Manager (CTM) is responsible for supporting or leading th...

Location

United States , Madison

Salary:

91000.00 - 155000.00 USD / Year

Exact Sciences

Expiration Date

Until further notice

Requirements

Bachelor’s degree in the life sciences or field as outlined in the essential duties
5+ years of experience in clinical research
1+ year of experience of experience leading project teams through the start-up, study conduct, data management, analysis, close out and report writing of clinical studies
Clinical monitoring experience including data review, query resolution, protocol deviation identification/tracking/trending, site initiation, site maintenance, and site closeout visits
Experience writing, reviewing and editing protocols
Knowledge of applicable quality standards (e.g. Good Clinical Practices (ICH/GCP), ISO 20916) and applicable local and national regulations governing clinical research
Applicants must be currently authorized to work in country where work will be performed on a full or part-time basis
Demonstrated ability to perform the Essential Duties of the position with or without accommodation
Experience providing oversight to external vendors (e.g. CRO, central labs, call centers, DCT providers)

Job Responsibility

Coordinate and oversee the operational aspects of a study including planning, start-up, enrollment and close out activities
Prepare, review and implement study related plans and documents including project timelines, study protocols, informed consent forms (ICFs), recruitment plans, monitoring plans, study budgets, site contracts & budgets, vendor management plans and other essential clinical study documents
Develop plans for systems and materials required to support the efficient execution of clinical studies
Develop, implement and maintain tools to manage, monitor and report on study health & operations, project timelines, and study finances
Participate in study database development by reviewing and contributing to case report form (CRF) design, CRF completion guideline development, edit check & manual data review requirements, and participation in user acceptance testing (UAT)
Oversee sample management activities including planning, sample handling, kit supply management, sample shipping, processing, and resulting
Develop site recruitment plans and is responsible for the identification, selection, start-up and performance monitoring of clinical research sites
Develop study budgets and is responsible for accurately forecasting and managing study expenses
Oversee site contracting and study budget management
Oversee study and site management activities such as, training, data entry & query resolution, TMF maintenance

What we offer

Paid time off (including days for vacation, holidays, volunteering, and personal time)
Paid leave for parents and caregivers
A retirement savings plan
Wellness support
Health benefits including medical, prescription drug, dental, and vision coverage
Bonus eligibility

Fulltime

New

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

New

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

New

Study Start Up Associate II

We are currently seeking a Study Start Up Associate II to join our diverse and d...

Location

South Korea , Seoul

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in life sciences or a related field
Minimum of 2 years of experience in clinical research or regulatory affairs, with specific experience in study start-up activities
Strong understanding of regulatory requirements and guidelines for clinical trials, including ICH-GCP and local regulatory requirements
Excellent organizational and project management skills, with the ability to prioritize and manage multiple tasks simultaneously
Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams
Initial and Amendment for IRB Submission

Job Responsibility

Leading the preparation and submission of regulatory documents, including clinical trial applications, ethics committee submissions, and regulatory agency communications
Coordinating and liaising with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation
Managing and maintaining comprehensive and accurate records of regulatory submissions, approvals, and correspondence
Providing guidance and support to study teams on regulatory requirements and best practices for study start-up activities
Participating in process improvement initiatives to streamline study start-up processes and enhance 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

Study Start-up Manager

Amgen

Location:
United States

Category:
-

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
February 20, 2026

Looking for more opportunities? Search for other job offers that match your skills and interests.

Similar Jobs for Study Start-up Manager

Associate Director Study Start-up

Associate Director Study Start-Up

Study Start-up Manager

Manager, Clinical Operations, International

Senior Clinical Trial Manager

Director study start-up

Director Study Start-Up

Study Start Up Associate II

Study Start-up Manager

Amgen

Location:United States

Category:-

Contract Type:Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:February 20, 2026

Looking for more opportunities? Search for other job offers that match your skills and interests.

Similar Jobs for Study Start-up Manager

Associate Director Study Start-up

Associate Director Study Start-Up

Study Start-up Manager

Manager, Clinical Operations, International

Senior Clinical Trial Manager

Director study start-up

Director Study Start-Up

Study Start Up Associate II

Location:
United States

Category:
-

Contract Type:
Not provided

Job Posted:
February 20, 2026