Clinical Trial Manager (early oncology)
Top Benefits
About the role
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.
What You Will Be Doing
- Manage 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
- Leads or supports cross-functional trial teams, including vendors
- Ensures accurate and up-to-date trial information within relevant tracking systems and provide regular updates of trial progression to Clinical Operations Lead, Clinical Trial Lead, and other defined stakeholders
- Proactively identify and resolve issues that arise during trial conduct; manage escalation of trial-related issues
- Participate in or lead the development of core trial documents, trial plans and system set-up; participate in preparation and ensure operational excellence of protocol and implementation of appropriate systems, standards, and processes to ensure quality across investigative sites, vendors, and data
- Participate in or lead preparation of vendor requirements and project scope and selection of trial vendors; effectively manage interactions and escalations with vendor trial team
- Participate in or lead feasibility assessment and selection of countries and sites for trial conduct
- Participate in or facilitates site engagement and communications with investigators and/or staff to support trial milestones and deliverables
- Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participate in data reviews and review of statistical analysis plans
- Participate in or lead set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external trial team members
- Provide oversight and direction to trial team members for trial deliverables
- Manage clinical trial budget and associated vendor contracts, including tracking and data in associated systems
- Ensure quality and completeness of TMF for assigned clinical trials
- Participates in inspection readiness activities including coordination of clinical trial team deliverables
- Participate in the evaluation and implementation of patient-focused strategies for assigned trials, as applicable
- Responsible for the management of budgets, timelines and resources for assigned clinical trial responsibilities
Your profile
- BA/BS degree with at least 3 years clinical trial experience or advanced degree (MS/PhD/PharmD) with at least 2 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
- Experience in Phase I oncology
- Moderate (~25%) 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 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
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 to apply
About Nextrials, Inc.
Founded by bio-pharmaceutical researchers in 1999, Nextrials offers today’s most advanced e-clinical tools and services for speeding the delivery of lifesaving drugs and medical devices to market. An industry-recognized innovator in web-based software solutions for the life sciences industry, Nextrials’ goal is to dramatically improve the application of technology to clinical trial management. To this end, it has developed the only truly cohesive solution that melds sophisticated clinical trial management functionality with Electronic Data Capture (EDC) in a single, integrated package. Prism™ enables researchers to derive more value from clinical data in real-time, accelerating the time to market for new drugs and devices, improving trial safety and monitoring, substantially lowering development costs. Prism has been globally deployed in North and South America, Western, Central and Eastern Europe, Asia, Africa, and Australia.
Nextrials defines itself as a life sciences company that provides technology solutions for clinical research, not a technology vendor who sells to this vertical market. With this philosophy, Nextrials is well matched to assist even the smallest of research and development teams with a product that can be implemented quickly, cost effectively and without the need for expensive in-house IT staff – a good match for small and mid-size contract research organizations, academic institutions and pharmaceutical/biotechnology/medical device companies. In addition, Prism can be employed on a project by project basis or as an enterprise implementation.
As a lead innovator in the EDC industry, Nextrials is at the forefront of developing and improving the next generation of EDC technology – the integration of Electronic Health Record data (EHR) into EDC utilizing RFD – Retrieve Form for Data capture. Nextrials is the only fully integrated EDC system which allows for ease of RFD implementation.
Clinical Trial Manager (early oncology)
Top Benefits
About the role
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.
What You Will Be Doing
- Manage 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
- Leads or supports cross-functional trial teams, including vendors
- Ensures accurate and up-to-date trial information within relevant tracking systems and provide regular updates of trial progression to Clinical Operations Lead, Clinical Trial Lead, and other defined stakeholders
- Proactively identify and resolve issues that arise during trial conduct; manage escalation of trial-related issues
- Participate in or lead the development of core trial documents, trial plans and system set-up; participate in preparation and ensure operational excellence of protocol and implementation of appropriate systems, standards, and processes to ensure quality across investigative sites, vendors, and data
- Participate in or lead preparation of vendor requirements and project scope and selection of trial vendors; effectively manage interactions and escalations with vendor trial team
- Participate in or lead feasibility assessment and selection of countries and sites for trial conduct
- Participate in or facilitates site engagement and communications with investigators and/or staff to support trial milestones and deliverables
- Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participate in data reviews and review of statistical analysis plans
- Participate in or lead set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external trial team members
- Provide oversight and direction to trial team members for trial deliverables
- Manage clinical trial budget and associated vendor contracts, including tracking and data in associated systems
- Ensure quality and completeness of TMF for assigned clinical trials
- Participates in inspection readiness activities including coordination of clinical trial team deliverables
- Participate in the evaluation and implementation of patient-focused strategies for assigned trials, as applicable
- Responsible for the management of budgets, timelines and resources for assigned clinical trial responsibilities
Your profile
- BA/BS degree with at least 3 years clinical trial experience or advanced degree (MS/PhD/PharmD) with at least 2 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
- Experience in Phase I oncology
- Moderate (~25%) 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 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
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 to apply
About Nextrials, Inc.
Founded by bio-pharmaceutical researchers in 1999, Nextrials offers today’s most advanced e-clinical tools and services for speeding the delivery of lifesaving drugs and medical devices to market. An industry-recognized innovator in web-based software solutions for the life sciences industry, Nextrials’ goal is to dramatically improve the application of technology to clinical trial management. To this end, it has developed the only truly cohesive solution that melds sophisticated clinical trial management functionality with Electronic Data Capture (EDC) in a single, integrated package. Prism™ enables researchers to derive more value from clinical data in real-time, accelerating the time to market for new drugs and devices, improving trial safety and monitoring, substantially lowering development costs. Prism has been globally deployed in North and South America, Western, Central and Eastern Europe, Asia, Africa, and Australia.
Nextrials defines itself as a life sciences company that provides technology solutions for clinical research, not a technology vendor who sells to this vertical market. With this philosophy, Nextrials is well matched to assist even the smallest of research and development teams with a product that can be implemented quickly, cost effectively and without the need for expensive in-house IT staff – a good match for small and mid-size contract research organizations, academic institutions and pharmaceutical/biotechnology/medical device companies. In addition, Prism can be employed on a project by project basis or as an enterprise implementation.
As a lead innovator in the EDC industry, Nextrials is at the forefront of developing and improving the next generation of EDC technology – the integration of Electronic Health Record data (EHR) into EDC utilizing RFD – Retrieve Form for Data capture. Nextrials is the only fully integrated EDC system which allows for ease of RFD implementation.