California, US residents click here (https://www.unither.com/docs/UNITHER%20Applicant%20Notice%20-%20%2812-22-23%29%20Final%202.15.24%20Combined%20EN%20and%20French.pdf#page=9) .

The job details are as follows:

What We Do

We build on the strength of our research and development expertise and a distinctive, entrepreneurial culture that encourages diversity, innovation, creativity, sustainability, and, simply, fun. Since inception, our mission has been to find a cure for pulmonary arterial hypertension and other life-threatening diseases. Toward this goal we have successfully gained FDA approval for five medicines, we are always conducting new clinical trials, and we are working to create an unlimited supply of manufactured organs for transplantation.

We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC). Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs. At the same time, we seek to provide our shareholders with superior financial performance and our communities with earth-sensitive energy utilization.

Our company was founded by an entrepreneur whose daughter was diagnosed with a life-threatening condition. She sought to find treatment options and a cure for her daughter and patients like her. We are founder-led, and relentless in our pursuit of “medicines for life”. We continue to research and develop treatments for cardiovascular and pulmonary diseases, and other orphan diseases.

How you’ll contribute

Plan, implement and execute Clinical Monitoring activities for assigned studies. Functionally responsible for studies assigned to 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. This position is based remotely, anywhere in the continental United States and has a travel expectation of up to 20%.

Trial Duties/Key Responsibilities

• Serve as the functional lead and point of contact (POC) for all central and field Clinical Monitoring activities for designated studies. Utilize wide-ranging experience to independently resolve highly complex issues in creative and effective ways.

• Serve as the "Go to" lead 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. Interpret potential issues and recommend best practices and solutions.

• 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

• Manage data cleaning activities within electronic data capture (EDC) systems and study-specific portals

• Take ownership of Clinical Monitoring documentation for the electronic Trial Master File (eTMF), ensuring timely and accurate filing

• Mentor and guide 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

• Collaborate with cross-functional teams to develop 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 areas and industry standards

• Share lessons learned and integrate best practices to enhance performance in ongoing studies

Department Duties

• Assist with the interview and onboarding process for Monitoring Team Lead candidates and new team members

• Serve as a mentor to CRAs and junior MTLs, fostering the adoption of best practices for monitoring activities

• Serve as a Subject Matter Expert (SME) for monitoring systems/technology and contribute to the development of new departmental templates and tools

• Perform other duties as assigned

For this role you will need

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

• 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

• Demonstrated ability to work in clinical trial electronic systems including eTMF, EDC, IRT, CTMS and other vendor portals (i.e., imaging, EKG, spirometry, labs, etc.)

• Ability to successfully perform all aspects of site management

• Excellent understanding of relevant medical / therapeutic knowledge and medical terminology

• Excellent understanding of Code of Federal Regulations (21 CRF Part 11, 50, 54, 56, 312, 812), Good Clinical Practices (GCP), ISO 14155 and clinical trial process

• Competent end user of Microsoft Office suite (Outlook, Word, Excel, PowerPoint)

• Strong interpersonal and written/oral communication skills; including ability to present topics/study material to an audience

• Strong time management and organizational skills

• Attention to detail and accuracy in work

• Ability to multi-task and prioritize in a rapidly moving environment

The salary for this position ranges from $141,000 to $165,000 per year. In addition, this role is eligible for the Company’s short-term and long-term incentive programs. 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. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities .

The salary range is the range United Therapeutics Corporation in good faith believes is the range of possible compensation for this role at the time of this posting depending on the candidate’s experience, qualifications, geographic location, and other factors permitted by law. The Company may ultimately pay more or less than the posted range. This range may be modified in the future. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.

At United Therapeutics, you’ll realize quickly that it is not an ordinary place to work! When you join our company, you will learn, grow, contribute, have fun, and be challenged... all while making a difference in the lives of our patients.

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. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities

While United Therapeutics does not require vaccination for Covid-19 at this time, we strongly encourage all employees and visitors to remain up to date on vaccinations and boosters to protect one another from illness. Employees working in customer-facing roles must adhere and comply with customers’ credentialing guidelines, which may require vaccination against Covid -19, the influenza virus, and other illnesses that could be harmful to healthcare staff and patients.

United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities

We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success.

We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work.