Monitoring Team Lead​/Senior Monitoring Team Lead

Position: Monitoring Team Lead / Senior Monitoring Team Lead
California, US residents  () .

** 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

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.

Establish study-specific documentation; inclusive of the Clinical Monitoring Plan detailing field and central monitoring activities and collaboration with cross functional members/vendors for data cleaning, monitoring visit report annotations and letters (confirmation/follow-up), visit agenda templates, training materials and site-specific training matrix.

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

Meeting Attendance and Discussions

+ Actively engage in Clinical Monitoring department meetings

+ Prepare and present at Investigator and Study Coordinator Meetings, both in-person and virtually

+ Provide regular updates on Clinical Monitoring activities during internal team meetings

+ Lead Clinical Monitoring team teleconferences, including agenda preparation and minute distribution

+ Work with cross-functional teams to establish timelines and ensure milestone adherence for studies

Corporate, Therapeutic and Industry Training

+ Participate in relevant conferences, scientific meetings, and training sessions to stay informed about therapeutic…