Clinical Project Manager Ii/senior Clinical Project Manager

Clinical Project Manager II/Senior Clinical Project Manager

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.

The Clinical Project Manager II/Senior Clinical Project Manager will work independently to ensure the success of a local or regional clinical trial. This role provides oversight and coordination for the operational delivery of ongoing local/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, Statement of Work (SOW) oversight
• Ensure comprehensive protocol and process training for all study team members
• Manage resources allocated to the study, excluding staff management
• Review and endorse team member transition plans as necessary
• Assist in the preparation of interim and primary analysis reports
• Organize and oversee Investigator Meetings, ensuring effective coordination
• Perform all other duties as required

Minimum Requirements

• Education and Experience requirements for Clinical Project Manager II level:
• Bachelor's degree in related field and 8+ years of related clinical study management or project management experience in CRO/pharmaceutical operations and development
• Master's degree in related field and 6+ years of related clinical study management or project management experience in CRO/pharmaceutical operations and development
• Education and Experience requirements for Senior Clinical Project Manager level:
• Bachelor's degree in related field and 10+ years of related clinical study management or project management experience in CRO/pharmaceutical operations and development
• Master's degree in related field and 8+ years of related clinical study management or project management experience in CRO/pharmaceutical operations and development
• General therapeutic area education and training
• Ability to interact and communicate effectively, both verbally and in writing, within and outside clinical operations, with colleagues, upper management, Key Opinion Leaders, vendor personnel, and clinical investigators and site personnel
• Strong working knowledge of GCP/ICH regulations and guidelines
• Strong overall scientific and clinical/medical research background
• Experience and comfort in working both independently and as part of a cross-functional team
• Proficiency with MS Office Suite including Word, Excel, PowerPoint, and Outlook
• Experience with EDC and CTMS systems
• Commitment and ability to handle high workloads, demanding situations, and deadlines
• Ability to proactively identify potential issues and formulate potential course(s) of action

Preferred Qualifications

• Master's degree
• 3+ years of related experience as a CRA, Clinical Manager, and/or Project Manager in the biopharmaceutical industry highly preferred
• RN - Registered Nurse - State Licensure and/or Compact State Licensure
• Previous experience with all phases of clinical research
• Demonstrated leadership experience as evidenced by the ability to motivate teams, provide advanced planning analysis, provide strategic guidance by evaluating risks against departmental deliverables

Job Location & Travel

This position will be located at our Durham, NC office with a hybrid schedule of 4 days in office and the option to work 1 day each week from home. In office requirements could change based on business needs.

At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good.

Eligible employees may participate in the Company's comprehensive benefits suite of programs, including medical/dental/vision/prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more.