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Posted Job Title
Clinical Operations Manager
Job Profile Title
Clinical Research Monitoring Specialist Senior
Job Description Summary
The Gene Therapy Program (GTP) is entering a new era of unprecedented opportunity with the great potential to reshape the face of medicine as we know it. Our discoveries have set the stage for successful treatments and possibly even cures for devastating genetic diseases.
The laboratory of Dr. Jim Wilson, at GTP of the University of Pennsylvania, has been a leader in the development of innovative vector technology for close to three decades. We have emerged as the âœgo-toâ organization for public and private partners, who want to participate in the gene therapy space. Currently, we are positioned to lead another round of vector innovation and establish pre-clinical and clinical proof-of-concept in therapeutic applications of in-vivo genome editing.
Continuation of all GTP positions is contingent upon funding.
Due to the continued growth of our program, we are searching for a Clinical Operations Manager to accelerate the deployment and conduct of Natural History Studies for clinical development and in support of an international community of rare diseases.
As a Clinical Operations Manager, you will partner with the Clinical Research and other teams (internally and externally) to manage current multi-center, global natural history studies, as well as for the design and execution of future natural history studies. You will be accountable for the conduct, delivery, reporting, and data sharing for our ongoing studies. Additionally, you may contribute to the development of the Gene therapy Program portfolio by contributing to First in Human clinical trial design for programs under development at GTP, organizing and participating in Patient Advice Boards and Clinician Advisory Boards, and working with our Industry partners. Your responsibilities will include but are not limited to team coordination, IRB/protocol submissions, coordination with domestic and international clinical sites, assisting with the submission of study documents to relevant stakeholders and regulatory bodies.
You will interface both internally with other members of the clinical research team, the University of Pennsylvania Office of Clinical Research, and the GTP research teams as well as externally with the disease community. You should be comfortable working with scientists, clinical researchers, patients, foundations, and CRO partners. You will effectively liaise with community stakeholders (clinicians, patient groups, sponsors) to integrate technical considerations into your programs.Â
Qualified candidates will have experience with human-subject research or clinical trials, and be familiar with the clinical research process, including Good Clinical Practices and ICH guidelines.Â
Joining GTP offers you with unique opportunity to contribute to revolutionizing the practice of medicine for these under-served patient groups. Â
Bachelor'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+ years 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. Â Advanced degree in a related field preferred. Â
In-depth knowledge of Good Clinical Practices and ICH guidelines a must!
Strong interpersonal and communication skills, attention to detail, and organizational and planning skills .
Needs to have good troubleshooting and conflict resolution skills.
Job Location - City, State
Department / School
Perelman School of Medicine
$59,703.00 - $113,435.00
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.
Special Requirements Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.
Internal Number: JR00019717
About University of Pennsylvania
Penn has a long and proud tradition of intellectual rigor and pursuit of innovative knowledge, begun by Benjamin Franklin in 1740. That tradition lives today through the creativity, entrepreneurship, and engagement of our faculty, students, and staff. Academic life at Penn is unparalleled, with an undergraduate student body of 10,000 from every U.S. state and around the world. The entering class of 2015 is the most talented and diverse in Penn's history. Consistently ranked among the top 10 universities in the country, Penn welcomes an additional 10,000 students to our top-ranked graduate and professional schools.