Job Information
United Therapeutics Clinical Oversight Lead II/Senior Clinical Oversight Lead in Durham, North Carolina
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.
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