Clinical Project Manager II / Senior Clinical Project Manager at United Therapeutics in Rtp, NC

Job description

California, US residents click here . The job details are as follows: Who We Are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs. United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter’s pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option. Who You Are Imagine leading clinical studies that don't just meet milestones, but help redefine what's possible for patients waiting for better treatment options. As a Clinical Project Manager or Senior Clinical Project Manager, you'll have the autonomy to drive studies forward, the support of exceptional cross-functional teams, and a front-row seat to cutting-edge science. At United Therapeutics, our culture combines purpose, innovation, and determination with a genuine belief that work can be both meaningful and enjoyable. If you're a proactive problem-solver who thrives on ownership, collaboration, and making a real impact, you'll find both challenge and fulfillment here. Work independently to ensure the success of a local or regional clinical trial. Provide oversight and coordination for the operational delivery of ongoing local or regional clinical trials to ensure all required timelines are met as well as adherence to budget, quality, and performance expectations. Utilize advanced expertise and serve as the primary study contact for study-related communication, coordinating with teams, management, and vendors Independently oversee the entire lifecycle of clinical trials, from start-up to close-out Direct local or regional clinical trials, ensuring cross-functional activities align with study objectives Administer study budgets and timelines, maintaining high-quality standards and performance metrics Identify, resolve, or escalate any concerns regarding study timelines and deliverables promptly Proactively escalate performance related concerns with appropriate line management Manage protocol deviations/violations diligently, reducing their occurrence through proactive collaboration Collaborate with Clinical Operations to monitor key performance indicators, enhancing study efficiency Provide consistent updates on study progress to the project team and management Manage insourcing / outsourcing partners, ensuring compliance with standards and expectations Contribute to the development of study concepts, protocols, and critical study documents Engage in the creation of policies, guidelines, and SOPs, contributing to the advancement of Clinical Operations and Study Management Assess and enhance current processes, recommending improvements to management Ensure study conduct aligns with SOPs, ICH/GCP guidelines, and local regulations Manage vendor relationships, including selection, negotiation, implementation, and statement of work (SOW) oversight Ensure comprehensive protocol and process train