
location_on220, East Main Street, Downtown Durham, Durham, Durham County, North Carolina, 27701, United States
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, aiming to improve patient outcomes and population health worldwide. Our mission is driven by a relentless commitment to innovation and impact, seeking diverse talent with curious minds to help customers improve the lives of patients everywhere.
As a Post-Trial Access Manager for Continued Access, you will serve as the primary program contact for executing multiple global Post-Trial Access (PTA) programs. This role focuses on the provision of investigational products for treatment in a non-trial setting, under the care of a physician, following a patient's participation in a clinical trial. You will navigate a landscape governed by local laws and regulations, utilizing established mechanisms such as early access, named patient programs, and managed access programs to ensure uninterrupted patient access to investigational therapies.
In this position, you will lead cross-functional teams to drive decision-making regarding regulatory mechanisms, supply strategies, and safety reporting. Your day-to-day involves managing timelines and budgets, developing core program documents like Treatment Guidelines and Informed Consent Forms, and ensuring alignment across all PTA program decisions. You will collaborate closely with Supply Chain to forecast needs and manage vendor contracts, while monitoring program performance and quality to maintain inspection readiness. This role requires a proactive approach to solving operational challenges in a dynamic, evolving clinical development environment, ensuring that patients receive the care they need with minimal supervision.
We appreciate your interest in growing your career with us. All information and credentials submitted in your application must be truthful and complete. IQVIA maintains a zero-tolerance policy for candidate fraud; any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification or termination of employment. Please apply via our careers portal to be considered.
IQVIA is proud to be an equal opportunity employer. We consider qualified applicants regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. We are committed to integrity in our hiring process and fostering a culture where diverse talent contributes to our shared goal of improving patient lives.
Work model: On-site
220, East Main Street, Downtown Durham, Durham, Durham County, North Carolina, 27701, United States
Durham, North Carolina
Experience with automating processes, process mapping, and/or certification in Lean or Six Sigma.