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CLINICAL SAFETY MANAGER

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Posting Details

Posting Details

Reference Number 40-26999
Posted Job Title CLINICAL SAFETY MANAGER
School Name Perelman School of Medicine
Org CI-Center for Cellular Immunotherapy
Posted to the Web 10/02/2017
Posted Job/Salary Grade 028
Employment Type Exempt
Hours N/A
Position Type Full Time
Position Schedule 8-5pm
Months 12
Position Length Contingent Upon Funding
Position End Date
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.

School/Center Overview

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/

Duties

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 CCI’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.

Responsibilities:
* 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, 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

Qualifications
  • 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, are required.
    * RN preferred
    * 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.
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
Quick Link http://jobs.hr.upenn.edu/postings/31707

Posting Supplemental Questions

Required fields are indicated with an asterisk (*).

  1. * How did you hear about this employment opportunity?
    • Jobs@Penn
    • Contacted by a Penn Recruiter
    • Referred by a Penn Employee
    • Referred by a friend or family member
    • Higher Education Recruitment Consortium (HERC)
    • Inside Higher Ed
    • Indeed.com
    • Other Internet Advertisement
    • Linkedin
    • Twitter
    • Other Social Media Site
    • Professional Affiliation/Trade Website
    • Diversity Association/Publication Website
    • Heard about it at a conference or career fair
    • Apple One
    • Recruitment and/or staffing agency
  2. * What is your highest level of education completed?
    • Less than high school education
    • High School Diploma or GED
    • Vocational or Technical School
    • Associate's Degree or Two Year College
    • Bachelor's Degree
    • Master's Degree
    • PHD/MD/JD or equivalent doctoral degree
  3. * How many years of experience do you have related to this position?
    • 0 to 1 Year
    • 1 to 2 Years
    • 2 to 3 Years
    • 3 to 5 Years
    • 5 to 7 Years
    • 7 to 10 Years
    • Over 10 Years

Applicant Documents

Required Documents
  1. Resume
Optional Documents
  1. Cover Letter