ICON Strategic Solutions
Overview
Manager of Study Start Up
at ICON Strategic Solutions (ICON plc). ICON is a world-leading healthcare intelligence and clinical research organization that fosters an inclusive environment driving innovation and excellence. We are seeking a Manager, Study Start-Up to lead and oversee the start-up activities for clinical trials, ensuring processes are completed efficiently and in regulatory compliance. The role involves managing a team, collaborating with cross-functional departments, and liaising with sponsors to ensure successful and timely study initiation. Responsibilities
Managing and overseeing the end-to-end study start-up process, including site identification, feasibility, regulatory submissions, and site activation. Leading a team of study start-up professionals, providing guidance, mentorship, and support to ensure high performance and successful project delivery. Collaborating with sponsors, clinical operations, and regulatory teams to ensure compliance with local and global regulations and timelines for clinical trial initiation. Monitoring study start-up metrics, timelines, and budgets to ensure projects are delivered on time and within scope. Identifying potential risks and challenges in the start-up process and implementing strategies to mitigate delays or issues. Driving continuous improvement initiatives to optimize the study start-up process and enhance overall efficiency. Your Profile
Bachelor’s degree in life sciences, clinical research, or a related field. Advanced degree or project management certification is a plus. Extensive experience in clinical trial study start-up, with a strong understanding of global regulatory requirements and clinical operations. Proven leadership skills, with experience managing and mentoring teams in a fast-paced, deadline-driven environment. Excellent organizational and project management skills, with the ability to handle multiple studies and priorities simultaneously. Strong communication and stakeholder management skills, with the ability to collaborate effectively with sponsors and internal teams. Experience with process optimization and implementing best practices in study start-up activities. 3-5 years of CRO or Pharma experience What ICON Can Offer You
ICON emphasizes a diverse culture that rewards high performance and nurtures talent. In addition to a competitive salary, ICON offers a range of benefits focused on well-being and work-life balance for you and your family. Various annual leave entitlements A range of health insurance offerings to suit you and your family’s needs Competitive retirement planning offerings Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of professionals for well-being support Life assurance Flexible country-specific optional benefits, including childcare vouchers, gym discounts, subsidized travel passes, health assessments, among others Our benefits section on the ICON careers site provides additional details. ICON is committed to inclusion, anti-discrimination, and equal opportunity for all qualified applicants. If you need a reasonable accommodation for any part of the application process, please let us know or submit a request here. We encourage you to apply even if you don’t meet every requirement, as there may be a fit for this role or other roles at ICON. If you are a current ICON employee, please apply here.
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Manager of Study Start Up
at ICON Strategic Solutions (ICON plc). ICON is a world-leading healthcare intelligence and clinical research organization that fosters an inclusive environment driving innovation and excellence. We are seeking a Manager, Study Start-Up to lead and oversee the start-up activities for clinical trials, ensuring processes are completed efficiently and in regulatory compliance. The role involves managing a team, collaborating with cross-functional departments, and liaising with sponsors to ensure successful and timely study initiation. Responsibilities
Managing and overseeing the end-to-end study start-up process, including site identification, feasibility, regulatory submissions, and site activation. Leading a team of study start-up professionals, providing guidance, mentorship, and support to ensure high performance and successful project delivery. Collaborating with sponsors, clinical operations, and regulatory teams to ensure compliance with local and global regulations and timelines for clinical trial initiation. Monitoring study start-up metrics, timelines, and budgets to ensure projects are delivered on time and within scope. Identifying potential risks and challenges in the start-up process and implementing strategies to mitigate delays or issues. Driving continuous improvement initiatives to optimize the study start-up process and enhance overall efficiency. Your Profile
Bachelor’s degree in life sciences, clinical research, or a related field. Advanced degree or project management certification is a plus. Extensive experience in clinical trial study start-up, with a strong understanding of global regulatory requirements and clinical operations. Proven leadership skills, with experience managing and mentoring teams in a fast-paced, deadline-driven environment. Excellent organizational and project management skills, with the ability to handle multiple studies and priorities simultaneously. Strong communication and stakeholder management skills, with the ability to collaborate effectively with sponsors and internal teams. Experience with process optimization and implementing best practices in study start-up activities. 3-5 years of CRO or Pharma experience What ICON Can Offer You
ICON emphasizes a diverse culture that rewards high performance and nurtures talent. In addition to a competitive salary, ICON offers a range of benefits focused on well-being and work-life balance for you and your family. Various annual leave entitlements A range of health insurance offerings to suit you and your family’s needs Competitive retirement planning offerings Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of professionals for well-being support Life assurance Flexible country-specific optional benefits, including childcare vouchers, gym discounts, subsidized travel passes, health assessments, among others Our benefits section on the ICON careers site provides additional details. ICON is committed to inclusion, anti-discrimination, and equal opportunity for all qualified applicants. If you need a reasonable accommodation for any part of the application process, please let us know or submit a request here. We encourage you to apply even if you don’t meet every requirement, as there may be a fit for this role or other roles at ICON. If you are a current ICON employee, please apply here.
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