ICON Clinical Research
Senior Site Management Associate- Remote
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
As a Clinical Trail Associate you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
What You Will Be Doing:
What you will be doing:
Support the day-to-day operations of assigned trials and responsibilities to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements
Responsible for maintaining accurate and up-to-date trial information within relevant tracking systems and provide regular updates as requested to trial team and other defined stakeholders
Participate in the development of core trial documents and trial level plans, as requested
Participate in or lead trial related systems set-up including implementation and maintenance of appropriate systems, standards and processes to ensure quality across investigative sites, vendors and data
Participate in feasibility assessment and selection of countries and sites for trial conduct
Participate in CRO and vendor set-up and management during clinical trial execution, as requested by clinical trial lead and/or clinical team
Participate in or facilitates site engagement and communications with investigators and/or staff to support trial milestones and deliverables
Participate in CRO and vendor set-up and management during clinical trial execution, as requested by clinical trial lead and/or clinical team
Ensure quality and completeness of TMF for assigned clinical trials
Participate in trial team meetings and manage associated documentation as requested
Participate in data cleaning and data review activities as requested
Participate in or lead set-up and implementation of effective investigator and site monitor training
Participate in the coordination and implementation of patient-focused strategies for assigned trials, as applicable
Responsible for complying with regulations, GCP, SOPs and established standards during trial set-up, conduct and close-out
Your Profile:
BA/BS degree with at least two years clinical trial experience
Must have strong knowledge of ICH/GCP guidelines and regulatory requirements.
Must have knowledge of protocol and clinical drug development processes, clinical trial design, trial planning and management, and monitoring
Requires project management skills and trial leadership ability
Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability
Fluent in English
Moderate (10%) travel required
What ICON can offer you:
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
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.
Visit our careers site (https://careers.iconplc.com/benefits) to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here (https://careers.iconplc.com/reasonable-accommodations)
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here (https://wd3.myworkday.com/icon/d/task/1422$1235.htmld) to apply
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
As a Clinical Trail Associate you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
What You Will Be Doing:
What you will be doing:
Support the day-to-day operations of assigned trials and responsibilities to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements
Responsible for maintaining accurate and up-to-date trial information within relevant tracking systems and provide regular updates as requested to trial team and other defined stakeholders
Participate in the development of core trial documents and trial level plans, as requested
Participate in or lead trial related systems set-up including implementation and maintenance of appropriate systems, standards and processes to ensure quality across investigative sites, vendors and data
Participate in feasibility assessment and selection of countries and sites for trial conduct
Participate in CRO and vendor set-up and management during clinical trial execution, as requested by clinical trial lead and/or clinical team
Participate in or facilitates site engagement and communications with investigators and/or staff to support trial milestones and deliverables
Participate in CRO and vendor set-up and management during clinical trial execution, as requested by clinical trial lead and/or clinical team
Ensure quality and completeness of TMF for assigned clinical trials
Participate in trial team meetings and manage associated documentation as requested
Participate in data cleaning and data review activities as requested
Participate in or lead set-up and implementation of effective investigator and site monitor training
Participate in the coordination and implementation of patient-focused strategies for assigned trials, as applicable
Responsible for complying with regulations, GCP, SOPs and established standards during trial set-up, conduct and close-out
Your Profile:
BA/BS degree with at least two years clinical trial experience
Must have strong knowledge of ICH/GCP guidelines and regulatory requirements.
Must have knowledge of protocol and clinical drug development processes, clinical trial design, trial planning and management, and monitoring
Requires project management skills and trial leadership ability
Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability
Fluent in English
Moderate (10%) travel required
What ICON can offer you:
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
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.
Visit our careers site (https://careers.iconplc.com/benefits) to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here (https://careers.iconplc.com/reasonable-accommodations)
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here (https://wd3.myworkday.com/icon/d/task/1422$1235.htmld) to apply