CrawlJobs Logo

Study Start Up Associate II

iconplc.com Logo

iconplc

Location Icon

Location:
South Korea , Seoul

Category Icon
Category:
Research and Development

Job Type Icon

Contract Type:
Not provided

Salary Icon

Salary:

Not provided
Save Job
Save Icon
Apply Position

Job Description:

We are currently seeking a Study Start Up Associate II to join our diverse and dynamic team. As a Study Start Up Associate II at ICON, you will play a pivotal role in leading the initiation of clinical trials, ensuring compliance with regulatory requirements, and contributing to the advancement of inNvative treatments and therapies.

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

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
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

Additional Information:

Job Posted:
February 19, 2026

Work Type:
Remote work
Icon
iconplc - All Job Offers
Job Link Share:
Copy Link Icon
Facebook Icon Twitter Icon LinkedIn Icon
PREMIUM
More languages and countries
+ Unlock 31697 hidden job offers
Languages
English Čeština Deutsch Ελληνικά Español Français +15
Countries
United States United Kingdom India Canada Australia +
See plans
Plans from $2.99 / month

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

Briefcase Icon

Similar Jobs for Study Start Up Associate II

Start Up Project Manager II- FSP

The Start Up Project Manager is responsible for defining, developing and deliver...
Location
Location
Canada
Salary
Salary:
Not provided
parexel.com Logo
Parexel
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Demonstrated clinical research experience
  • Demonstrated start up experience
  • Demonstrated project management experience
  • Global start up experience (Exposure across a minimum of North America, Asia and Europe) across multiple therapeutic areas
  • Concurrent management of complex processes within and across countries in multiple regions of the world
  • Technical expertise in the use of software for the management of clinical studies (enterprise project management, off the shelf and custom built) including reporting systems (dashboards with associated medium to complex data analysis)
  • Expert ability to comprehend status and adapt communications across a diverse audience
  • Perform critical path analysis across multiple related project plans, will use key performance indicators to assist in driving overall delivery to operational plan across roles
  • Will use generative artificial intelligence techniques in daily work
  • Uses risk management techniques as standard to identify and mitigate key project delivery risks
Job Responsibility
Job Responsibility
  • Partner with country / site feasibility specialists to incorporate up to date intelligence for the planned countries and sites into the overall start up strategy and site activation plan, most typically on studies with a medium to large country and site footprint
  • Partner and co-ordinate across teams responsible for regulatory submissions (local and country) and start up functions (e.g. site essential document collection, site contracts and budgets) to align country and site activities, will have ability to form a robust startup strategy and site activation plan for operationally complex studies
  • The SUPM is responsible for delivering site activations to plan, for the SUPM II this will generally be for studies with higher operational complexity (based on a combination of factors such study design, country and site footprint and the priority of the study)
  • As part of the responsibility of delivering site activations to plan the SUPM will co-ordinate with many different roles working at the study and country level to oversee progress of the study specific (e.g. Vendor set-up, investigational product supply etc.) or country specific tasks (e.g. Regulatory submissions, importer of record for supplies etc.) that need to be completed in order for site activations in turn to complete
  • Provide project management of activities directly required to complete all site activations for an assigned study as part of a study management led team to complete all start up activities for a study
  • Lead start up meetings that facilitate alignment of site selection to activation activities performed by country level start up roles with the endorsed trial optimization plan (by senior leadership)
  • The SUPM will work with country level start up roles to seek opportunities to accelerate site activations for their study
  • Accountable for quality and completeness of start up timeline plans at study, country and site level within an enterprise project management (EPM) system
  • Responsible for creating and overseeing the initial baseline and subsequent snapshots of timeline planning within the EPM system
  • In conjunction with study management roles is responsible for ensuring consistent participant compensation for sites and institutions taking part in multiple studies concurrently to eliminate knock-on impact across studies
Read More
Arrow Right

Study Start Up Associate II

ICON plc is a world-leading healthcare intelligence and clinical research organi...
Location
Location
Mexico , Mexico City
Salary
Salary:
Not provided
iconplc.com Logo
iconplc
Expiration Date
Until further notice
Flip Icon
Requirements
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
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
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.
Read More
Arrow Right

Study Start Up Associate II

ICON plc is a world-leading healthcare intelligence and clinical research organi...
Location
Location
South Korea , Seoul
Salary
Salary:
Not provided
iconplc.com Logo
iconplc
Expiration Date
Until further notice
Flip Icon
Requirements
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
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
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
Read More
Arrow Right

Senior Clinical Trial Manager

ICON plc is a world-leading healthcare intelligence and clinical research organi...
Location
Location
Mexico , Mexico City
Salary
Salary:
Not provided
iconplc.com Logo
iconplc
Expiration Date
Until further notice
Flip Icon
Requirements
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
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
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
Read More
Arrow Right

Associate Director / Director, Data Management

Reporting to the Senior Director, Clinical Data Management, the Associate Direct...
Location
Location
United States , Cambridge
Salary
Salary:
185000.00 - 260000.00 USD / Year
beamtx.com Logo
Beam Therapeutics
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • BS or MS degree in a scientific or health-related field
  • 10+ years of experience in clinical data management within pharmaceutical/biotech and/or CRO environments
  • Demonstrated sponsor-side ownership of Phase I, II and III studies, from start-up through closure for multiple clinical studies
  • Strong hands-on experience with EDC systems (e.g., Medidata RAVE, Veeva EDC, Oracle Inform)
  • Deep knowledge of CDASH/CDISC, GCP/ICH, and FDA regulatory expectations
  • Proven experience overseeing CROs and external data vendors
  • Experience developing reports using J-Review and/or other CDM reporting tools
  • Prior IND, as well as NDA/BLA (filing/submission) experience, is highly desirable
  • Must be self-motivating, with strong analytical, organizational, and communication skills, with the ability to manage complexity across multiple studies
  • Demonstrated ability to navigate evolving priorities and drive timelines forward with focus and composure in a fast-moving organization
Job Responsibility
Job Responsibility
  • Lead sponsor side clinical data management activities across multiple concurrent studies within a defined therapeutic area
  • Own data management execution from study start-up through database lock and archival for concurrent studies, including late stage and registrational trials
  • Ensure data quality, integrity, and traceability to support interim analyses, CSRs, DSURs, IB updates, and program specific regulatory interactions
  • Proactively identify data risks, trends, and operational dependencies
  • Serve as the primary data management contact for CROs and third-party data vendors
  • Oversee outsourced CDM activities to ensure timely, high-quality deliverables aligned with sponsor’ expectations
  • Monitor CRO and vendor performance, escalating risks and proposing mitigation strategies
  • Contribute expert input to the development and evolution of data management standards, processes, tools/systems and vendor operating models
  • Provide hands-on leadership for CRF design and cross functional review, Edit check specifications and user acceptance testing, Data Management Plans and CRF Completion Guidelines, External data transfer specifications
  • Apply CDASH/CDISC expertise and partner with Statistical Programming to support SDTM readiness, validation outputs, Reviewer’s Guides, and define.xml
  • Fulltime
Read More
Arrow Right

Clinical Research Associate II

As a Clinical Research Associate (CRA) at Parexel, you act as an integral part t...
Location
Location
India , Bengaluru
Salary
Salary:
Not provided
parexel.com Logo
Parexel
Expiration Date
Until further notice
Flip Icon
Requirements
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
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
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
Read More
Arrow Right

Site Care Partner II

The Site Care Partneris a key Pfizer point of contact for investigative sites th...
Location
Location
Taiwan , Taipei
Salary
Salary:
Not provided
pfizer.de Logo
Pfizer
Expiration Date
Until further notice
Flip Icon
Requirements
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
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
Read More
Arrow Right
New

Overnight Associate

To provide customer service by completing assigned tasks relating to receiving a...
Location
Location
Canada , Corner Brook
Salary
Salary:
16.15 CAD / Hour
walmart.com Logo
Walmart
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Age – 16 or older
Job Responsibility
Job Responsibility
  • Preparing the sales floor for store opening
  • Setting, merchandising and signing features
  • Completing live unloading of other types of merchandise
  • The main differentiator between this role and day/evening fulfillment is there is a stronger emphasis on labelling and placing merchandise in the backroom bins/stocking
  • Pulling pallets of merchandise to and from the sales floor for overnight processing
  • Assisting in stocking the sales floor as assigned and providing customer service if necessary
  • Label the sales floor for store opening
  • Contributes to a safe, clean and hazard free work environment through adherence to Company policy and procedures, including the completion of safety sweep logs and ensuring displays and fixtures are secure
  • Parttime
Read More
Arrow Right