Director, Global Regulatory Affairs Study Start Up
hace 3 días
.Director, Global Regulatory Affairs Study Start Up (level dependent on experience) - This position is open to candidates globally Manages and oversees global RASSU activities.
Provides guidance to RASSU regional leaders and fosters their collaboration and growth.
Ensures clinical study timelines, budgets, and quality measures are met and meet / exceed accepted corporate standards.
Embraces and implements programs that ensure quality and efficient RASSU activities.
Attracts, develops, coaches, and retains high-performance team members, empowering them to elevate their levels of responsibility, span of control, and performance.
Prepares and manages departmental budgets and implements cost-effective measures.
Ensures Global Standard Operating Procedures (GSOPs) are reviewed and updated in a timely manner and abide by local guidelines and regulations.
Oversees and administers training of all RASSU staff.
Ensures appropriate staff review of GSOPs.
Ensures Quality Assurance (QA) suggestions and findings are addressed in a timely manner.
Represents CTI in developing new business, assisting with Clinical Operations presentations, reviewing bid proposals, and reviewing and facilitating out-of-scope (OOS) activities.
Embraces departmental collaboration and harmonization on a global platform to streamline study start up and ensure continual process improvement, increase efficiencies and advances technology/software utilization.
Drives organizational change and process harmonization within the global RASSU organization.
Manages departmental financial metrics to meet corporate objectives.
What You'll Bring: At least 15 years of CRO or relevant experience, including previous experience managing large global teams and multinational complex aspects of global Regulatory Affairs and study start up activities.
MS or PhD degree in health-related area or equivalent experience as determined by CTI Management and Human Resources.
About CTI CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations.
We assist clinical research throughout the lifecycle of development, from drug concept to commercialization.
CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms.
For more information, visit.
Why CTI?
Advance Your Career – We invest in your professional growth.
Our structured mentoring program, leadership development courses, and dedicated training department provide the support you need to excel.
We also encourage ongoing education to help you achieve your professional goals.
Join an Award-Winning Team – Join a global team spanning 60 countries, recognized for its award-winning culture that prioritizes people.
We support your work-life balance with hybrid work opportunities
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Madrid, España Cti Clinical Trial And Consulting Services A tiempo completo.Director, Global Regulatory Affairs Study Start Up (level dependent on experience) - This position is open to candidates globallyManages and oversees global RASSU activities.Provides guidance to RASSU regional leaders and fosters their collaboration and growth.Ensures clinical study timelines, budgets, and quality measures are met and meet / exceed accepted...
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