Overview
As a Global Study Manager you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Responsibilities
The
Global Study Manager
provides input to the overall operational trial(s) implementation, manages trial(s) timelines, budget, feasibility, country identification and sites selection, enhanced patient recruitment, functions as the primary liaison for internal stakeholders and vendors, leads multidisciplinary departments initiatives, and provides support for process changes to increase efficiency in study executions. Essential Functions of the Job (Key responsibilities) Accountable to deliver Trial(s) on time, within budget, and with highest achievable quality. Assist in the review, development and/or writing of clinical trial documents and manuals, including but not limited to Protocol, Case Report Forms, informed consent forms, Clinical Study Report and other regulatory documents. Manage the evaluation and selection of investigative sites; responsible for feasibility. Select, coordinate and monitor activities of vendors. Review of monitoring reports and conduct co-monitoring visits, as needed. Develop and manage trial(s) timelines, budget and priorities. Participate in data review and discrepancy resolution. Ensure set up and maintain all systems in order to plan and implement trial(s) and track progress. Generate reports to update management on conduct of trial. Ensure appropriate clinical trial supply plans are implemented and managed. Develop recruitment plans, risk-mitigation plan, monitor, and implement contingencies as required. Participate in monitoring study safety. Develop key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determine appropriate action in conjunction with study team. Perform initial review of CRO and other third party study vendor invoices to ensure that work is performed in accordance with scope of work. Assist with CRA and third party vendor training on protocols and practices. Lead the multi-disciplinary trials teams; include the study team meetings. Function as the primary contact for trial(s) between Drug Development and other departments. Assume responsibility to participate as a member of working groups and perform special projects, as assigned, to improve the efficiency, effective and quality of the functioning of the Development Operations Department. Ensure adherence to Good Clinical Practice and all applicable local and international regulations. Qualifications You are: BS/BA degree or a relevant degree with strong emphasis on science. Minimum of five years of experience in the biopharmaceutical industry or other relevant clinical research experience in the conduct and management of multinational clinical trials. Able to manage complex and/or large trials. Must have working knowledge of ICH Good Clinical Practices and other relevant regulatory/health authority experience. Ability to effectively manage multiple priorities across several protocols and therapeutic areas simultaneously. Demonstrate leadership and problem solving skills. Experience in executing a wide range of clinical trial activities (from initiation to clinical study report). Used to work in a multidisciplinary setting, strong cooperative team player, ability to be flexible and adapt to a changing environment. Good planning, prioritization, problem solving and organizational skills; strong customer-orientation, used to work independently. Strong communication skills, used to communicate with a broad range of stakeholders and to build strong positive relationships. 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 maximise savings and plan with confidence for the years ahead Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others Visit our careers website to read more about the benefits of working at ICON:
https://careers.iconplc.com/benefits At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organisation. 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 through the form below. 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. #LI-Remote #LI-RS1
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Global Study Manager
provides input to the overall operational trial(s) implementation, manages trial(s) timelines, budget, feasibility, country identification and sites selection, enhanced patient recruitment, functions as the primary liaison for internal stakeholders and vendors, leads multidisciplinary departments initiatives, and provides support for process changes to increase efficiency in study executions. Essential Functions of the Job (Key responsibilities) Accountable to deliver Trial(s) on time, within budget, and with highest achievable quality. Assist in the review, development and/or writing of clinical trial documents and manuals, including but not limited to Protocol, Case Report Forms, informed consent forms, Clinical Study Report and other regulatory documents. Manage the evaluation and selection of investigative sites; responsible for feasibility. Select, coordinate and monitor activities of vendors. Review of monitoring reports and conduct co-monitoring visits, as needed. Develop and manage trial(s) timelines, budget and priorities. Participate in data review and discrepancy resolution. Ensure set up and maintain all systems in order to plan and implement trial(s) and track progress. Generate reports to update management on conduct of trial. Ensure appropriate clinical trial supply plans are implemented and managed. Develop recruitment plans, risk-mitigation plan, monitor, and implement contingencies as required. Participate in monitoring study safety. Develop key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determine appropriate action in conjunction with study team. Perform initial review of CRO and other third party study vendor invoices to ensure that work is performed in accordance with scope of work. Assist with CRA and third party vendor training on protocols and practices. Lead the multi-disciplinary trials teams; include the study team meetings. Function as the primary contact for trial(s) between Drug Development and other departments. Assume responsibility to participate as a member of working groups and perform special projects, as assigned, to improve the efficiency, effective and quality of the functioning of the Development Operations Department. Ensure adherence to Good Clinical Practice and all applicable local and international regulations. Qualifications You are: BS/BA degree or a relevant degree with strong emphasis on science. Minimum of five years of experience in the biopharmaceutical industry or other relevant clinical research experience in the conduct and management of multinational clinical trials. Able to manage complex and/or large trials. Must have working knowledge of ICH Good Clinical Practices and other relevant regulatory/health authority experience. Ability to effectively manage multiple priorities across several protocols and therapeutic areas simultaneously. Demonstrate leadership and problem solving skills. Experience in executing a wide range of clinical trial activities (from initiation to clinical study report). Used to work in a multidisciplinary setting, strong cooperative team player, ability to be flexible and adapt to a changing environment. Good planning, prioritization, problem solving and organizational skills; strong customer-orientation, used to work independently. Strong communication skills, used to communicate with a broad range of stakeholders and to build strong positive relationships. 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 maximise savings and plan with confidence for the years ahead Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others Visit our careers website to read more about the benefits of working at ICON:
https://careers.iconplc.com/benefits At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organisation. 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 through the form below. 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. #LI-Remote #LI-RS1
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