Study Start Up Associate II Job at iconplc (Seoul)

Study Start Up Associate II

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

Bachelor’s Degree completed preferably in Life Sciences
Minimum of 2 -4 years’ experience or understanding of clinical study start up requirements and activities. (USA sites as preference)
Knowledge of local and/or international regulatory processes, including submissions to regulatory authorities and ethics committees.
Previous experience using CTMS, goBalto, Veeva Vault, TMFs, etc.
Ability to read and understand clinical protocols, regulatory documents, and study-specific processes.
Strong attention to detail and organizational skills.
Ability to work independently and manage multiple tasks simultaneously in a fast-paced environment.
Excellent communication skills both in English

Job Responsibility

Proficient knowledge of ICON SOPs/WPs, ICH/GCP and applicable country regulations/guidelines and ICON systems.
Support Site Partners to collect, review, organize and assemble initial start-up and maintenance submission packages to Central EC/IRB, Local EC/IRB, Competent Authorities, any other local regulatory authorities as required by countries and in accordance with ICH/GCP and applicable country regulations/guidelines.
Support collection and assembling of all documents needed in the Critical Document Package (CDP) and/or those required for site activation, ensuring that Sponsor and Investigator obligations are being met and are in compliance with applicable requirements and ICH/GCP guidelines.
Support coordination of all necessary translations required for any start-up documentation.
Perform timely and accurate progress data entry of all documents collected from sites and of the relevant study site activation activities into the appropriate tracking systems and tools.
Participate to internal study review meetings with study teams to provide updates on site progress in document collection and on the executed site activation tasks.
Accurately forecast Site Activation plans and ensure that they are reflected accurately in ICON’s systems and proactively follow through for achievement to plan.
Ensure accuracy and timely completeness of Trial Master File (TMF) documents submitted during start-up and perform a Quality Control (QC) review of files before transfer to maintenance for filing in TMF.
Attend study team meetings as required

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 II

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

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 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
Fluency in English

Job Responsibility

Collection essential documents
Quality check of the collected essential documents
Filing the collected documents in Veeva and Box
May be involved in feasibilities
No IRB Submission

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

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

Clinical Research Associate II

As a Clinical Research Associate (CRA) at Parexel, you act as an integral part t...

Location

India , Bengaluru

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Substantial start up experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology
Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience
Demonstrate strong problem-solving skills
Able to take initiative and work independently, and to proactively seek guidance when necessary
Excellent presentation skills
Client focused approach to work
Ability to interact professionally within a client organization
Flexible attitude with respect to work assignments and new learning
Ability to prioritize multiple tasks and achieve project timelines
utilizing strong analytical skills to make decision autonomously due to the unpredictable nature of the issues that arise

Job Responsibility

Act as Parexel’s direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase
Build relationships with investigators and site staff
Support on request country specific feasibility and/or site pre-qualification and qualification activities
Manage country and site level TMF issues ensuring documents’ First Time Quality (FTQ) as well as providing direct resolution to reported site problems
Develop strategy to configure, distribute, collect, and review and approve, high quality country specific and/or site specific documents or essential regulatory documents
Customize, review, and negotiate as needed, country/site specific Informed Consent Forms (ICF), translations, and customize and negotiate any amendments
Prepare and submit IRB/IEC and MoH/RA (if applicable) application(s), resolving conflicts, determining appropriate follow up until receipt of final approval
Submit all pertinent documentation to the trial master file as per project plans/sponsor/company policy
Forecast, develop, manage, and revise plans and strategies for IRB/IEC and MoH / RA submission/approval and Site activation
Update and maintain appropriate Clinical Trial Management System (CTMS) in a timely manner

What we offer

Patient-focused in everything we do
Supportive and inclusive environment
Career growth and development
Flexible work arrangements
Diverse therapeutic areas and project exposure
Advanced Technology

Clinical Research Coordinator II

The Clinical Research Office is responsible for reading/understanding/following ...

Location

United States , Los Angeles

Salary:

70304.00 - 116563.00 USD / Year

Children's Hospital Los Angeles

Expiration Date

Until further notice

Requirements

3+ year experience in clinical trial coordination
1+ years pediatric clinical trials experience required
Bachelor’s degree or associates degree in related scientific field
ACRP Certified Clinical Research Coordinator (CCRC) or SOCRA Certified Clinical Research Professional (CCRP)
Candidates with a medical degree are exempt from certification requirement

Job Responsibility

Reading/understanding/following clinical research protocols
Coordinating specimen collections, processing, shipment, storage
Coordinating manufacturing/receipt of treatment
Assisting with extracting data from EMR and original source and reporting
Safety reporting
IRB submissions for new studies, amendments, continuing reviews, close outs
Maintaining regulatory binders
Starting up new studies- budgets/contracts
Reading/understanding Medical Coverage Analysis, IRB application, ancillary department approvals, regulatory documents
Invoicing for the study

What we offer

Competitive compensation package
Robust benefits program

Fulltime

Site Care Partner II

The Site Care Partneris a key Pfizer point of contact for investigative sites th...

Location

Taiwan , Taipei

Salary:

Not provided

Pfizer

Expiration Date

Until further notice

Requirements

Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience (estimate at least 7 years’ experience)
Proficiency in local language preferred. English is required
Work as SCP I experience above 2 years
Demonstrated experience in site management with prior experience as a CRA/ Site monitor
Demonstrated experience in start up activities through to site activation
Demonstrated experience in conduct and close out activities
Demonstrated knowledge of quality and regulatory requirements in applicable countries
Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
Must demonstrate good computer skills and be able to embrace new technologies
Excellent communication, presentation and interpersonal skills

Job Responsibility

Accountable for site start-up and activation
Deploy GSSO site strategies by qualifying and activating assigned sites
Supports processes to optimize country & site selection activities including review and assessment of the draft potential site list & provide PTA output for site selection
Supports the Feasibility Strategy and Analytics Lead to ensure that high quality feasibility results are delivered
Collaborate with key stakeholders providing country/regional level input to country outreach surveys including protocol feasibility, country SOC and medical practices (as applicable)
Provide country/regional level input to country strategy, feasibility and protocol design in collaboration with relevant Medical Affairs colleagues, and with input from external clinical experts as required
Maintain a knowledge of assigned protocols
Conduct study start up activities at the site level including but not limited to PTA, coordination of site activation checklist items, ICD finalization, SIV (as applicable), including management of issues that may compromise time to site activation
Ensure all the site initiation activity including training per site activation checklist, collect and / complete necessary documentation/ systems needed for site activation. (e.g. PSR, SART, ESRA, SAC, FU Letter, Planisware, ISF/eISF etc.)
Support country specific ICD review and deployment when applicable

Fulltime

New

Project Controls Coordinator III

Under the direction of the Supervisor Project Controls, the Analyst will perform...

Location

Canada , North York

Salary:

55.00 - 58.00 CAD / Hour

Randstad

Expiration Date

June 03, 2026

Requirements

Four Year Degree or combination of education and related experience
Minimum of 5 years of Project Controls or Project Management experience
Project Management professional designation is preferred
Experienced analytical skills including Earned Value Management
An independent worker within a team setting
Demonstrated professional engagement at a high level with work group, stakeholders, and contractors in a team setting
Proficient in the use of SAP, Oracle and MS office suite, intermediate+ Excel skills
Excellent communication, interpersonal, and organizational skills
Ability to effectively manage and prioritize workload, bring issues forward and develop working relationships at all levels of the organization
Detail oriented and understands the importance of data reconciliation

Job Responsibility

Analyze and maintain the project costs at the WBS level including control budget, incurred costs, commitments, and forecast
Provide the project team with accurate and timely cost information and reporting
Perform earned value measurements to anticipate forecast impacts
Perform monthly project close processes and prepare monthly project reports and comparative capital cost estimates for the project in Excel and EcoSys
Prepare and document project change orders timely in accordance with Project Management Office standards
Engage the Project Managers in meetings and discussions to review and reforecast project costs
Review cost transactions to ensure accurate project costs
Communicate with larger Controls team for the project
Liaise with Project Managers and Field Cost Analysts to ensure engagement with the project progress, changes, highlights and issues
Maintain the project Work Breakdown Structure such that it facilitates project execution and cost control during project execution and meets accounting requirements for asset creation and project closeout

Fulltime

New

Mechanical Engineer - Energy Solutions

Join a Team of engineers dedicated to working hand-in-hand with large manufactur...

Location

Canada , North York

Salary:

65.00 - 68.00 CAD / Hour

Randstad

Expiration Date

May 09, 2026

Requirements

Engineering Degree preferred, Chemical or Mechanical Engineering preferred
Membership in Professional Engineers of Ontario or similar professional organization is preferred
Proven skills in: leading and influencing without explicit authority
time management
Ability to work independently but work within team of like-minded professionals
Valid driver’s license with a responsible driving record is needed

Job Responsibility

Identify new contacts and conduct at large manufacturing facilities to for the purpose to arrange site visits
Attend joint-site visits with team members to support in the identification and quantification of potential energy savings projects
Balance multiple priorities: Able to effectively manage time and priorities, consistently delivering in firm annual savings targets
Quantify impact and secure buy-in: Build technical savings calculations, sometimes from scratch, to support project justification and persuade key stakeholders on execution of work
Provide solutions to complex problems: expertly analyze complex operations across various industries and synthesize available information to create solutions equally appealing to business and technical people
Forge long-term customer relationships: build and nurture professional relationships founded on unwavering trust and mutual respect, being a first-choice energy efficiency partner for your customers
Continuous growth and curious mindset: Proactively identify new savings opportunities to drive both short and long-term work and build a sales funnel for sustained growth
Drive results autonomously while thriving in a collaborative environment: Play a supporting role in managing a small group customer base and integrate into, and support broader Team to achieve personal and collective objectives

What we offer

Hybrid Work Model: in-Office (Monday, Tuesday & Thursday) Remote (Wednesday & Friday)

Study Start Up Associate II

iconplc

Location:
South Korea , Seoul

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
February 19, 2026

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

Similar Jobs for Study Start Up Associate II

Study Start Up Associate II

Study Start Up Associate II

Senior Clinical Trial Manager

Clinical Research Associate II

Clinical Research Coordinator II

Site Care Partner II

Project Controls Coordinator III

Mechanical Engineer - Energy Solutions

Study Start Up Associate II

iconplc

Location:South Korea , Seoul

Category:Research and Development

Contract Type:Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:February 19, 2026

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

Similar Jobs for Study Start Up Associate II

Study Start Up Associate II

Study Start Up Associate II

Senior Clinical Trial Manager

Clinical Research Associate II

Clinical Research Coordinator II

Site Care Partner II

Project Controls Coordinator III

Mechanical Engineer - Energy Solutions

Location:
South Korea , Seoul

Category:
Research and Development

Contract Type:
Not provided

Job Posted:
February 19, 2026