ICON Clinical Research
Local Trial Manager - US
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.
We are currently seeking a Senior Clinical Trial Manager to join our diverse and dynamic team. As the Senior Clinical Trial Manager, you will hold a crucial role in ensuring the successful delivery of all clinical aspects of the studies. Your expertise and leadership will be instrumental in managing the clinical portion of the budget, developing effective monitoring plans, and driving enrollment to meet project objectives. Moreover, you will liaise with stakeholders, identify and mitigate risks, and provide comprehensive reporting on all clinical activities.
What you will be doing:
Planning, management, and oversight of clinical study execution in accordance with the global program strategy, through leadership of the cross-functional Local Study Team (LST).
Supports country-level operational planning and accountable for site selection within assigned country/-ies.
Contributes and develops to program/study-specific materials - e.g., monitoring plan, study specific training documents.
Supports and contributes to Clinical Study Teams (CSTs) / Trial Management Teams (TMTs) as applicable, agenda driven, present at meetings.
Communicates country status (including timelines and deliverables) to key stakeholders (e.g., Global Clinical Managers [GCM], Program Managers, CST or TMT, Development Operations Manager [DOM] etc) with oversight as required and ensures updates to relevant systems.
Accountable for site-level goal setting and study-specific deliverables for clinical sites within their country/-ies.
Contributes to, deliver and/or lead CRA, Investigator and Study Coordinator training.
Provides oversight and monitoring of applicable vendor activities e.g., laboratories and equipment provisioning.
Engages with local cluster team and local functions from a study perspective (e.g., Local Medical Affairs team, DOM)
Provides country level input into the Country Operational Plan (COP) and partner with the DFM through feasibility and with the GCMs to ensure local delivery of the study.
Responsible for approval of Baseline and Revised Enrolment Plans (Country Level)
Contributes to the study-level forecast for investigational product, support study level accountability and reconciliation across assigned countries, management of ELE (enrolment long-range estimates) process.
Monitors the execution of the clinical study against timelines, deliverables, and budget for that country.
Translates global start up requirements into local country targets
Monitors country enrolment and retention and act on deviations from plan. Identify barriers to enrolment and support recruitment and retention strategic solutions.
Monitors and acts upon data flow metrics - review, trend identification and analysis, with targeted follow up where appropriate.
Monitors and reviews country and study trends.
Reviews Monitoring Visit Reports.
Identifies and facilitates resolution of cross-functional study-specific issues.
Provides updates regarding the study budget and obtains approval for budget deviations for clinical sites (outside of range).
Escalates any issues related to delivery, timelines, or budget to GCMs (or TMT le ad if appropriate).
Escalates CRA performance issues to applicable Clinical Trial Oversight Manager.
Conducts on-site quality visits with CRAs where/when appropriate and supports the maintenance of site relationships.
Basic Qualifications:
Doctorate degree OR
Master's degree & 3 years of directly related experience OR
Bachelor's degree & 5 years of directly related experience OR
Associate's degree & 10 years of directly related experience
Preferred Qualifications:
BA/BS/BSc
Minimum 2-3 years' experience of leading local/regional trials
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.
We are currently seeking a Senior Clinical Trial Manager to join our diverse and dynamic team. As the Senior Clinical Trial Manager, you will hold a crucial role in ensuring the successful delivery of all clinical aspects of the studies. Your expertise and leadership will be instrumental in managing the clinical portion of the budget, developing effective monitoring plans, and driving enrollment to meet project objectives. Moreover, you will liaise with stakeholders, identify and mitigate risks, and provide comprehensive reporting on all clinical activities.
What you will be doing:
Planning, management, and oversight of clinical study execution in accordance with the global program strategy, through leadership of the cross-functional Local Study Team (LST).
Supports country-level operational planning and accountable for site selection within assigned country/-ies.
Contributes and develops to program/study-specific materials - e.g., monitoring plan, study specific training documents.
Supports and contributes to Clinical Study Teams (CSTs) / Trial Management Teams (TMTs) as applicable, agenda driven, present at meetings.
Communicates country status (including timelines and deliverables) to key stakeholders (e.g., Global Clinical Managers [GCM], Program Managers, CST or TMT, Development Operations Manager [DOM] etc) with oversight as required and ensures updates to relevant systems.
Accountable for site-level goal setting and study-specific deliverables for clinical sites within their country/-ies.
Contributes to, deliver and/or lead CRA, Investigator and Study Coordinator training.
Provides oversight and monitoring of applicable vendor activities e.g., laboratories and equipment provisioning.
Engages with local cluster team and local functions from a study perspective (e.g., Local Medical Affairs team, DOM)
Provides country level input into the Country Operational Plan (COP) and partner with the DFM through feasibility and with the GCMs to ensure local delivery of the study.
Responsible for approval of Baseline and Revised Enrolment Plans (Country Level)
Contributes to the study-level forecast for investigational product, support study level accountability and reconciliation across assigned countries, management of ELE (enrolment long-range estimates) process.
Monitors the execution of the clinical study against timelines, deliverables, and budget for that country.
Translates global start up requirements into local country targets
Monitors country enrolment and retention and act on deviations from plan. Identify barriers to enrolment and support recruitment and retention strategic solutions.
Monitors and acts upon data flow metrics - review, trend identification and analysis, with targeted follow up where appropriate.
Monitors and reviews country and study trends.
Reviews Monitoring Visit Reports.
Identifies and facilitates resolution of cross-functional study-specific issues.
Provides updates regarding the study budget and obtains approval for budget deviations for clinical sites (outside of range).
Escalates any issues related to delivery, timelines, or budget to GCMs (or TMT le ad if appropriate).
Escalates CRA performance issues to applicable Clinical Trial Oversight Manager.
Conducts on-site quality visits with CRAs where/when appropriate and supports the maintenance of site relationships.
Basic Qualifications:
Doctorate degree OR
Master's degree & 3 years of directly related experience OR
Bachelor's degree & 5 years of directly related experience OR
Associate's degree & 10 years of directly related experience
Preferred Qualifications:
BA/BS/BSc
Minimum 2-3 years' experience of leading local/regional trials
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