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Responsibilities
Responsible for coordinating the operational and strategic aspects for Clinical Trial SubmissionsEssential Functions:Lead the clinical trial submission process from strategy development through to regulatory approval.Develop, plan, and coordinate submission strategies to ensure timely and successful trial submissions.Facilitate discussions with cross-functional stakeholders, consolidate input, and drive alignment on CTR submission strategies.Coordinate and manage submissions through the Clinical Trials Information System (CTIS) portal.Perform quality control reviews of CTIS applications and submission packages prior to submission.Oversee financial planning, budgeting, and tracking activities related to clinical trial submissions.Qualifications3 to 5 years of experience preparing and managing Clinical Trial Regulation (CTR) submissions.Strong knowledge of Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and applicable regulatory requirements, with the ability to apply them effectively in a clinical research environment.Experience in regulatory affairs and clinical trial submissions.Proven project management skills, with the ability to coordinate multiple activities and meet deadlines in a fast-paced environment.IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.comYou’ll work remotely, with the flexibility to do your best work from home. Supported by collaborative tools and a global team, you’ll stay connected while enjoying the autonomy and balance that comes with a fully remote role.Culture at IQVIA is built on a shared belief: that when people are empowered with better data, smarter technology and deeper expertise, they can change what’s possible for patients. Across every team and every corner of the globe, you’ll find colleagues who genuinely care — about the mission and about each other. That’s what makes this a place where people tend to stay, grow and do the best work of their careers.
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