Job Details
Monitoring Team Lead / Senior Monitoring Team Lead
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:**
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 areas and industry standards
+ Share lessons learned and integrate best practices to enhance performance in ongoing studies
Department Duties
+ Serve as a mentor to CRAs to foster the adoption of best practices for monitoring activities
+ Perform other duties as assigned
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
+ Demonstrated ability to work in clinical trial electronic systems including eTMF, EDC, IRT, CTMS, and other vendor portals (i.e., imaging, EKG, spirometry, lab, etc.)
+ Ability to track personal finances for expense reporting and regular submission for payment
+ 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
+ Responsible for working within the established budgets for a given clinical project
+ 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 multitask and prioritize in a rapidly moving environment
+ Competent end user of Microsoft Office suite (Outlook, Word, Excel, PowerPoint)
Job Location & Travel
This position can be located remotely in either the Eastern or Central time zone. This position requires up to 20% travel.
The salary range for the Monitoring Team Lead position is $105,500 - $140,000 per year, and the salary range for the Senior Monitoring Team Lead position is $126,500 - $165,000. These ranges reflect our good-faith estimate of the compensation for this role at the time of posting. An employee's position within the salary range will be based on factors such as education, qualifications, experience, skills, geographic location, and business needs, as well as other factors permitted by law at the time of posting. This range may be modified in the future based on company and market factors.
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. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities
United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and 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._
**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 areas and industry standards
+ Share lessons learned and integrate best practices to enhance performance in ongoing studies
Department Duties
+ Serve as a mentor to CRAs to foster the adoption of best practices for monitoring activities
+ Perform other duties as assigned
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
+ Demonstrated ability to work in clinical trial electronic systems including eTMF, EDC, IRT, CTMS, and other vendor portals (i.e., imaging, EKG, spirometry, lab, etc.)
+ Ability to track personal finances for expense reporting and regular submission for payment
+ 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
+ Responsible for working within the established budgets for a given clinical project
+ 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 multitask and prioritize in a rapidly moving environment
+ Competent end user of Microsoft Office suite (Outlook, Word, Excel, PowerPoint)
Job Location & Travel
This position can be located remotely in either the Eastern or Central time zone. This position requires up to 20% travel.
The salary range for the Monitoring Team Lead position is $105,500 - $140,000 per year, and the salary range for the Senior Monitoring Team Lead position is $126,500 - $165,000. These ranges reflect our good-faith estimate of the compensation for this role at the time of posting. An employee's position within the salary range will be based on factors such as education, qualifications, experience, skills, geographic location, and business needs, as well as other factors permitted by law at the time of posting. This range may be modified in the future based on company and market factors.
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. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities
United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and 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._
Job #NLX292199154