Clinical Oversight Lead II/Senior Clinical Oversight Lead - United Therapeutics
Durham, NC
About the Job
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
Perform activities that will provide oversight of sites, vendors, and United Therapeutics staff responsible for conducting clinical trial activities. Compile and report quality metrics, building effective relationships with internal and external customers and ensuring continuous improvement in the conduct of clinical trial activities. This is a hybrid position in our RTP, NC office with 4 days a week onsite and 1 day a week work from home. This position has a 15% travel expectation, and could include both domestic and international travel.
+ Develop clinical oversight plans (Quality Management, Protocol Deviations, Vendor Oversight, etc.) to oversee overall study quality, including the oversight of vendors and contractors assigned to all UT studies
+ Perform ongoing data review pertinent to clinical oversight activities
+ Develop reporting that highlights areas of concern and outlines investigations, action plans, and resolution
+ Collect and analyze qualitative and quantitative results from quality oversight activities
+ Communicate concerns arising from oversight visits to appropriate clinical staff
+ Address concerns and resolve issues through on-site assessment and training when potential compliance issues are identified
+ Assist in the development and presentation of continuing education based on findings from oversight activities
+ Collaborate with GXP Compliance/QA to identify trends resulting from GXP Compliance/QA audits
+ Responsible for identifying areas for process improvement
+ Support clinical team in preparing for external audits
+ Facilitate GXP Compliance/QA audit activities for clinical development to include root cause analysis, corrective action preventative action (CAPA) and effectiveness checks using Quality Management System technology as appropriate
+ Maintain strong working knowledge of SOP’s, ICH, GCP, regulatory requirements and guidelines
+ Provide staff support by being a contact point for information and advice relating to ICH, GCP, relevant UT-SOP’s, local regulations and guidelines
+ Support the provision and delivery of training concerning ICH, GCP, relevant UT-SOP’s, local regulations and guidelines
+ Support the design, development and implementation of clinical training programs within Global Clinical departments
+ Perform other duties as required
For this role you will need
Minimum Requirements
+ Bachelor’s Degree (scientific related field preferred)
+ For Clinical Oversight Lead II level:
+ 8+ years of experience in biopharmaceutical research & development or CRO
+ For Senior Oversight Lead level:
+ 10+ years of experience in biopharmaceutical research & development or CRO
+ Excellent understanding of the clinical research process, including US FDA, EU, and GCP regulations, and the function of quality control in clinical trial conduct
+ Experience with developing SOPs and department processes
+ Experience with training and mentoring clinical research staff
+ Experience with Clinical systems technology, e.g. EDC, CTMS, eTMF
+ Proficiency with Microsoft Office products and email
Preferred Qualifications
+ 8+ years of relevant clinical oversight experience as a CRA and/or Clinical Manager in the biopharmaceutical industry
+ Experience with quality assurance audits
+ Experience with clinical project management and/or clinical operations management
+ Experience with risk assessment and management
+ Experience with data analytics, and data manipulation
+ Experience with process improvement and CAPA management, including root cause analysis
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.
_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._
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
Perform activities that will provide oversight of sites, vendors, and United Therapeutics staff responsible for conducting clinical trial activities. Compile and report quality metrics, building effective relationships with internal and external customers and ensuring continuous improvement in the conduct of clinical trial activities. This is a hybrid position in our RTP, NC office with 4 days a week onsite and 1 day a week work from home. This position has a 15% travel expectation, and could include both domestic and international travel.
+ Develop clinical oversight plans (Quality Management, Protocol Deviations, Vendor Oversight, etc.) to oversee overall study quality, including the oversight of vendors and contractors assigned to all UT studies
+ Perform ongoing data review pertinent to clinical oversight activities
+ Develop reporting that highlights areas of concern and outlines investigations, action plans, and resolution
+ Collect and analyze qualitative and quantitative results from quality oversight activities
+ Communicate concerns arising from oversight visits to appropriate clinical staff
+ Address concerns and resolve issues through on-site assessment and training when potential compliance issues are identified
+ Assist in the development and presentation of continuing education based on findings from oversight activities
+ Collaborate with GXP Compliance/QA to identify trends resulting from GXP Compliance/QA audits
+ Responsible for identifying areas for process improvement
+ Support clinical team in preparing for external audits
+ Facilitate GXP Compliance/QA audit activities for clinical development to include root cause analysis, corrective action preventative action (CAPA) and effectiveness checks using Quality Management System technology as appropriate
+ Maintain strong working knowledge of SOP’s, ICH, GCP, regulatory requirements and guidelines
+ Provide staff support by being a contact point for information and advice relating to ICH, GCP, relevant UT-SOP’s, local regulations and guidelines
+ Support the provision and delivery of training concerning ICH, GCP, relevant UT-SOP’s, local regulations and guidelines
+ Support the design, development and implementation of clinical training programs within Global Clinical departments
+ Perform other duties as required
For this role you will need
Minimum Requirements
+ Bachelor’s Degree (scientific related field preferred)
+ For Clinical Oversight Lead II level:
+ 8+ years of experience in biopharmaceutical research & development or CRO
+ For Senior Oversight Lead level:
+ 10+ years of experience in biopharmaceutical research & development or CRO
+ Excellent understanding of the clinical research process, including US FDA, EU, and GCP regulations, and the function of quality control in clinical trial conduct
+ Experience with developing SOPs and department processes
+ Experience with training and mentoring clinical research staff
+ Experience with Clinical systems technology, e.g. EDC, CTMS, eTMF
+ Proficiency with Microsoft Office products and email
Preferred Qualifications
+ 8+ years of relevant clinical oversight experience as a CRA and/or Clinical Manager in the biopharmaceutical industry
+ Experience with quality assurance audits
+ Experience with clinical project management and/or clinical operations management
+ Experience with risk assessment and management
+ Experience with data analytics, and data manipulation
+ Experience with process improvement and CAPA management, including root cause analysis
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.
_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._
Source : United Therapeutics