Clinical Operations Manager

Location
Pennsylvania, United States
Posted
25 May 2020
End of advertisement period
25 Jul 2020
Ref
JR00019717
Contract Type
Permanent
Hours
Full Time

University Overview

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.

Posted Job Title

Clinical Operations Manager

Job Profile Title

Manager Research Project A

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 “go-to” 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.

Job Description

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. 

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. 

Joining GTP offers you with unique opportunity to contribute to revolutionizing the practice of medicine for these under-served patient groups.

Qualifications:

  • 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 3+ 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.  Advanced degree in a related field preferred.  
  • 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

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$50,684.00 - $91,232.00

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.

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