Study Start Up Associate Job at iconplc (Seoul)

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

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

Senior Clinical Trial Manager

ICON plc is a world-leading healthcare intelligence and clinical research organi...

Location

Mexico , Mexico City

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

A minimum of 5 years of experience as a Senior Clinical Trial Manager, ideally having progressed through CTM I and CTM II, for a total of 7+ years of CTM experience
Strong experience managing North America and Canada, including: ICF creation
Advarra IRB
Local IRB management
Canada MOH submissions
Demonstrated experience managing LATAM studies end-to-end, from Start-Up through Close-Out
Excellent English proficiency (reading, writing, and speaking)
Bachelor’s degree in health, life sciences, or another relevant field

Job Responsibility

Budget Oversight Oversee the clinical portion of the budget to ensure efficient resource allocation
Ensuring Effective Study Oversight: Develop monitoring plans and tools, ensuring effective study oversight
Optimizing Performance: Train and mentor Clinical Research Associates (CRAs) to optimize their performance
Timely Study Start-Up & Enrollment: Drive enrollment and lead study start-up activities, adhering to timelines
Improving Study Integrity Review trip reports and implement corrective and preventative action plans when necessary
Building Productive Relationships: Foster productive relationships with Sponsors, vendors, and cross-functional teams

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

New

Senior Study Start Up Associate

Senior Study Start Up Associate - São Paulo (FSP - Sponsor Dedicated). ICON plc ...

Location

Brazil , São Paulo

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree or local equivalent and/or appropriate experience from the Medical/science background and/or discipline
Solid experience or understanding of clinical study start-up requirements and activities
Fluency in the local language and English is essential

Job Responsibility

Efficiently Drive Study Initiation: Conduct feasibility assessments, site identification, site contract negotiation, and other critical SSU activities
Empower Success through Specialized SSU Expertise: Provide expertise to Study Start Up team leads and project teams, providing valuable insights to drive success
Ensuring Regulatory Compliance: Prepare and coordinate submissions to regulatory, ethics, and other relevant bodies, ensuring compliance with all necessary regulations and guidelines
Safeguarding Patient Welfare: Contribute to the development, finalization, and review of Master and Country Specific Subject Information Sheets/Informed Consent Forms, guaranteeing the highest standards of patient safety and informed consent

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

Senior Clinical Trial Manager

ICON plc is a world-leading healthcare intelligence and clinical research organi...

Location

Brazil , Sao Paulo

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

A minimum of 4+ years of experience in a Clinical Trial Management position at a CRO or Pharmaceutical Organization
Bachelor's degree in health, life sciences, or other relevant fields of study
At least 10+ years of relevant experience in clinical trial management
Preferred: 2+ years of monitoring experience
Experience in managing complex or global trials is advantageous
Preferred: Experience in managing all trial components from start-up to database lock
Preferred: Experience in coaching/mentoring other CTMs, leading a team of CTMs, and participating in departmental initiatives
Fluency in English (reading, writing, speaking)

Job Responsibility

Budget Oversight Oversee the clinical portion of the budget to ensure efficient resource allocation
Ensuring Effective Study Oversight: Develop monitoring plans and tools, ensuring effective study oversight
Optimizing Performance: Train and mentor Clinical Research Associates (CRAs) to optimize their performance
Timely Study Start-Up & Enrollment: Drive enrollment and lead study start-up activities, adhering to timelines
Improving Study Integrity Review trip reports and implement corrective and preventative action plans when necessary
Building Productive Relationships: Foster productive relationships with Sponsors, vendors, and cross-functional teams

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

Clinical Trial Manager

Clinical Trial Manager - Home Based - Sponsor dedicated. ICON plc is a world-lea...

Location

Brazil , Sao Paulo

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

A minimum of 4+ years of experience in a Clinical Trial Management position at a CRO or Pharmaceutical Organization
Bachelor's degree in health, life sciences, or other relevant fields of study
At least 10+ years of relevant experience in clinical trial management
Preferred: 2+ years of monitoring experience
Experience in managing complex or global trials is advantageous
Preferred: Experience in managing all trial components from start-up to database lock
Preferred: Experience in coaching/mentoring other CTMs, leading a team of CTMs, and participating in departmental initiatives
Fluency in English (reading, writing, speaking)

Job Responsibility

Budget Oversight Oversee the clinical portion of the budget to ensure efficient resource allocation
Ensuring Effective Study Oversight: Develop monitoring plans and tools, ensuring effective study oversight
Optimizing Performance: Train and mentor Clinical Research Associates (CRAs) to optimize their performance
Timely Study Start-Up & Enrollment: Drive enrollment and lead study start-up activities, adhering to timelines
Improving Study Integrity Review trip reports and implement corrective and preventative action plans when necessary
Building Productive Relationships: Foster productive relationships with Sponsors, vendors, and cross-functional teams

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

Senior Clinical Trial Manager

ICON plc is a world-leading healthcare intelligence and clinical research organi...

Location

United States , Boston

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

A minimum of 4+ years of experience in a Clinical Trial Management position at a CRO or Pharmaceutical Organization
Bachelor's degree in health, life sciences, or other relevant fields of study
At least 10+ years of relevant experience in clinical trial management
Fluency in English (reading, writing, speaking)

Job Responsibility

Budget Oversight Oversee the clinical portion of the budget to ensure efficient resource allocation
Ensuring Effective Study Oversight: Develop monitoring plans and tools, ensuring effective study oversight
Optimizing Performance: Train and mentor Clinical Research Associates (CRAs) to optimize their performance
Timely Study Start-Up & Enrollment: Drive enrollment and lead study start-up activities, adhering to timelines
Improving Study Integrity Review trip reports and implement corrective and preventative action plans when necessary
Building Productive Relationships: Foster productive relationships with Sponsors, vendors, and cross-functional teams

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 Associate

iconplc

Location:
South Korea , Seoul

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
March 04, 2026

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