Monitoring Team Lead / Senior Monitoring Team Lead

Monitoring Team Lead/Senior Monitoring Team Lead

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 Monitoring Team Lead/Senior Monitoring Team Lead will plan, implement and execute Clinical Monitoring activities for assigned studies. They will be functionally responsible for study assigned Clinical Monitoring team members (central, field, contract and permanent staff), monitoring activities, and support of study sites to ensure compliance with United Therapeutics Corporation (UTC) process, applicable regulations and industry guidance throughout the duration of the trial.

Trial Duties/Responsibilities:

• Serve as the functional lead and point of contact (POC) for all central and field Clinical Monitoring activities for designated studies.
• Work independently to select methods and techniques and evaluation criteria for problem-solving and decision making
• Utilize advanced functional expertise and maintain accountability for the delivery of clinical monitoring services for assigned studies
• Perform on-site visits, central data reviews, analytics reviews, and site management tasks to support monitoring efforts
• Establish, execute, and continuously assess the Clinical Monitoring team's performance, including the Clinical Monitoring Plan, the enrollment/recruitment plan, and the data cleaning plan
• Analyze site trends and monitoring team performance metrics to identify areas for proactive improvement
• Provide feedback on CRA performance to Clinical Monitoring Management and support cross-functional team member evaluations
• Collaborate with cross functional teams to assure comprehensive training for the Clinical Monitoring team on study protocols, therapeutic areas, and project-specific systems
• Create and refine monitoring tools, such as annotated monitoring visit reports (MVRs), communication templates, and checklists, to support the Clinical Monitoring team's efficiency
• Assist Clinical Research Associates (CRAs) in resolving significant site issues, including serious adverse event SAE reconciliation, compliance matters, and action items (AIs)
• Oversee the scheduling and execution of monitoring visits, ensuring effective site management coordination
• Ensure visit documentation is reviewed and approved in accordance with UTC SOPs
• Coordinate data cleaning activities within electronic data capture (EDC) systems and study-specific portals
• Serve as the owner of Clinical Monitoring documentation for the electronic Trial Master File (eTMF), ensuring timely and accurate filing
• Serve as a mentor for the Clinical Monitoring team, including conducting training/co-monitoring visits when necessary
• Meet with cross-functional teams to establish timelines and ensure milestone adherence for studies

Minimum Requirements:

• Bachelor's degree in a biological or related life sciences; nursing qualifications or relevant clinical research experience in pharmaceutical/biotech/medical device or CRO industries may be considered
• For the Monitoring Team Lead level: 8+ years of experience working in pharmaceutical, biotech, medical device, or CRO industry with progressive experience working in clinical trials 6+ years of relevant monitoring experience as a clinical research associate (CRA) 1+ years of Lead CRA experience
• For the Senior Monitoring Team Lead level: 10+ years of working in pharmaceutical/biotech/medical device or CRO industry with progressive experience working in clinical trials 8+ years of relevant monitoring experience 4+ years of oversight and management of clinical monitoring team at the study level

Job Location & Travel:

This position can be located remotely in either the Eastern or Central time zone. This position requires up to 20% travel.