Study Start Up Associate I Job at iconplc (Mexico City)

Senior Study Start Up Associate

Study Start Up Associate I- IND Submission-Home based-South Korea- ICON Strategi...

Location

South Korea , Seoul

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in life sciences or a related field
Previous experience in clinical research or regulatory affairs preferred, but not required
Strong attention to detail and organizational skills
Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams
Ability to work independently and manage multiple tasks simultaneously in a fast-paced environment

Job Responsibility

Assisting in the preparation and submission of regulatory documents, such as clinical trial applications and ethics committee submissions
Coordinating with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation
Maintaining accurate and up-to-date records of regulatory submissions and approvals
Supporting study teams in the development of study documents, including protocols, informed consent forms, and investigator brochures
Participating in study start-up meetings and providing input on regulatory requirements and timelines

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

Study Start Up Associate

Study Start Up Associate homebased France! ICON plc is a world-leading healthcar...

Location

France , Paris; Lyon

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in life sciences or a related field
Previous experience in clinical research or regulatory affairs preferred, but not required
Strong attention to detail and organizational skills
Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams
Ability to work independently and manage multiple tasks simultaneously in a fast-paced environment

Job Responsibility

Assisting in the preparation and submission of regulatory documents, such as clinical trial applications and ethics committee submissions
Coordinating with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation
Maintaining accurate and up-to-date records of regulatory submissions and approvals
Supporting study teams in the development of study documents, including protocols, informed consent forms, and investigator brochures
Participating in study start-up meetings and providing input on regulatory requirements and timelines

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

Study Start-Up Associate - home-based - South Korea- ICON Strategic Solutions. I...

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

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 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

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 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

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.

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

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Study Start Up Associate I

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Study Start Up Associate I

Senior Study Start Up Associate

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Study Start Up Associate II

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Study Start Up Associate II

Associate Director Study Start-up

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