University of Pennsylvania DIRECTOR OF REGISTRIES in Philadelphia, Pennsylvania
DIRECTOR OF REGISTRIES Below you will find the details for the position including any supplementary documentation and questions you should review before applying for the opening. To apply for the position, please click the Apply for this Job link/button.
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Reference Number 40-29184
Posted Job Title DIRECTOR OF REGISTRIES
School Name Perelman School of Medicine
Org OD-Center for Orphan Disease Research and Therapy
Posted to the Web 08/07/2018
Posted Job/Salary Grade 029
Employment Type Exempt
Position Type Full Time
Position Schedule 8am - 5pm
Position Length Contingent Upon Funding
Position End Date
The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn’s distinctive interdisciplinary approach to scholarship and learning.
Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play.
The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more.
The Perelman School of Medicine at the University of Pennsylvania is the oldest and one of the finest medical schools in the United States. Penn is rich in tradition and heritage and at the same time consistently at the forefront of new developments and innovations in medical education and research. Since its founding in 1765 the School has been a strong presence in the community and prides itself on educating the leaders of tomorrow in patient care, biomedical research, and medical education. http://www.med.upenn.edu/
Orphan diseases represent a collection of disorders that afflict fewer than 200,000 individuals for any single disease type, yet there are more than 7,000 distinct orphan diseases. The Orphan Disease Center (ODC) in the Perelman School of Medicine was founded in 2011 to promote and fund research in rare diseases globally, beyond Penn, making a difference for these under-served patient populations. A unique aspect of ODC is that it is a ‘Center without walls’ which sources and contributes to developing transformative therapies through the use of platform technologies and of research strategies that can be deployed across multiple rare disease programs. The main feature is a pilot grant program which provides $8M annually to over 35 global institutions. The ODC has launched a new initiative to build a suite of rare disease patient registries using cloud-based technology. Our registries collect real-world demographic, clinical, and laboratory data in addition to patient (or caregiver) reported outcomes from patients with rare diseases. Data is securely collected through online portals, centralized, and de-identified for use by the broader scientific community. The data collected in these registries is essential for understanding rare diseases and accelerating the development of new treatments. As a part of this effort, we are seeking a Director of Registries, to lead the deployment and innovative use of registries for clinical development and in support of an international community of rare diseases. As the Director of Registries, you will lead our Clinical Programs Management team, having oversight of multiple workflows, timelines, and drive team accountability for deliverables as it relates to patient registries and their application to clinical trials and research. You will pro-actively identify potential risks to relevant stakeholders, strategizing with team on the development of tactical and achievable mitigation and contingency planning. You will hold Clinical Program Managers accountable for timely delivery of each project from initiation through the life cycle of patient registries. Your team is responsible for team coordination, IRB/protocol submissions, coordination with domestic and international clinical sites, assisting with submission of study documents to relevant stakeholders and regulatory bodies. You will interface both internally through a matrix environment and externally with the disease community and should be comfortable working with scientists, clinical researchers, patients, foundations, and our informatics partner. You will efficaciously liaise with community stakeholders (clinicians, patient groups, sponsors) in coordination with the Deputy Director, Senior Director and Directors of Therapeutic Development for Programs of Excellence to integrate technical considerations into the operations of the Project Teams. This may take several forms including initiating sub-meetings, informal networking or outreach, community interaction through social media. You should have experience with human-subject research or clinical trials, and be familiar with the clinical research process, including Good Clinical Practices and ICH guidelines.
- Master’s degree in a scientific or technical discipline (computer science, biology, public health, etc. or demonstrated professional experience preferably with data, analytics, software, or other related technical discipline) and 5 to 7 years of related work experience with human-subject research or clinical trial experience (academic, industry, or relevant clinical research organization) or an equivalent combination of education and experience required. PhD in a related field is preferred.* In-depth knowledge of Good Clinical Practices and ICH guidelines* Strong interpersonal and communication skills, attention to detail, and organizational and planning skills * Needs to have good troubleshooting and conflict resolution skills.
Affirmative Action Statement
Penn adheres to a policy that prohibits discrimination on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic origin, citizenship status, age, disability, veteran status, or any other legally protected class.
Quick Link http://jobs.hr.upenn.edu/postings/39052
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