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 Pennâ™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 Safety Manager
Job Profile Title
Clinical Research Monitoring Specialist Senior
Job Description Summary
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/
The Clinical Safety Manager plays a pivotal role in the Clinical Operations function by serving as an expert to the Center for Cellular Immunotherapy (CCI) organization. The Clinical Safety Manager facilitates continuous improvement of CCIâ™s proactive Serious Adverse Events (SAEs), Adverse Events (AEs), Safety reporting and Safety Management processes and systems, including development of standards, processes, and training for clinical safety oversight for all CCI clinical trials. The Manager monitors adherence to regulatory requirements (ICH, FDA, NIH, NCI, etc.) and GCP guidelines, leads efforts to identify potential compliance and quality risks to CCI safety management in clinical trials, and develops mitigation strategies with the assistance of clinical operations and QA personnel.
Develop Clinical Safety SOPs and Safety process Guide to Daily Operations
Partner and interface with the Office of Clinical Research (OCR) on safety activities related to the CCI clinical studies.
Collaborate with the CCI Medical Director, Â Study Medical Directors, Study Project Managers, Clinical Sites and Scientists in CCI to perform clinical safety to ensure high standards of clinical trial conduct and analysis
Develop Safety Reports, Quarterly Safety Reviews, Investigator Notification, CCI IMV AE analysis reports and safety reports for IND/RAC Annual Reports and DSMB meetings.
Provide AE and SAE guidance and SAE Form training
Position contingent upon funding
Bachelors degree and 5 to 7 years of experience in Clinical Safety Management, Clinical Development and Operations, and/or Clinical Quality
Assurance or an equivalent combination of education and experience is required.
Experience in SOP and process design related to clinical safety management
Extensive knowledge of FDA / global clinical trial regulations and ICH GCP Guidelines
Understanding of the clinical development process and clinical safety documentation requirements
Proactive approach to GCP clinical safety compliance
Attention to detail, excellent communication skills and be able to work within a team under challenging and sometimes stressful conditions
Exceptional knowledge of commonly-used clinical safety concepts, practices, and procedures within GCP area
Ability to work independently with minimal direction.
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: JR00009315
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.