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SR. CLINICAL TRIAL PROJECT MANAGER

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Posting Details

Posting Details

Reference Number 40-26988
Posted Job Title SR. CLINICAL TRIAL PROJECT MANAGER
School Name Perelman School of Medicine
Org SM-DN-Office of Clinical Research
Posted to the Web 10/16/2017
Posted Job/Salary Grade 031
Employment Type Exempt
Hours N/A
Position Type Full Time
Position Schedule 8:30-5:30
Months 12
Position Length Ongoing
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 Office of Clinical Research (OCR), under the direction of the Vice Dean for Clinical Research, is a central office in the Perelman School of Medicine (PSOM). OCR supports the management and conduct of clinical research while promoting compliance in dynamic environment rich in cutting edge scientific advancements and ensuring the highest level of participant safety. This is accomplished by standardizing the approach to clinical research across the various research centers and departments in the PSOM and supporting investigative teams through regulatory and operational assistance, and enhancements in study management and oversight. We are currently looking for a Senior Clinical Trial Project Manager to manage highly complex scientific projects and collaborations in the development of institutionally held INDs from preclinical to clinical. This position will support scientific advancement in the burgeoning Gene Therapy Program.

The Senior Clinical Trial Project Manager will lead cross-functional teams (including preclinical, data management, regulatory and business operations) in a matrixed environment with limited direction. He/she will plan and execute multiple domestic and international Phase I/II Clinical Trials to agreed timelines, scope, and budget. When applicable identify and oversee clinical vendors and adherence to contract, protocol and applicable regulations. He/she will guide project team activities, ensure team accountability for deliverables, and ensure projects meet defined milestones. The Senior Clinical Trial Project Manager will prepare and manage project budgets, create and manage clinical project timelines, project scope, and all project documentation. A significant portion of this role will require highly effective management of partner Contract Research Organizations (CROs). The incumbent will communicate and provide updates to relevant stakeholders, including senior institutional leadership, as to status of milestones.

Qualifications

The desired candidate must possess the minimum of a Master’s degree and 7 to 10 years of applicable clinical and/or scientific project management experience (preferably pharmaceutical industry/clinical operations experience), or an equivalent combination of education and experience. PhD highly desirable. An in-depth knowledge and experience in the application of Good Clinical Practice (GCP) regulations are required (e.g., ICH, FDA, NIH/NCI, etc.). Contract Research Organization and biologics experience background is highly desirable. Prior experience as a CRA in Phase I environment is preferred. Has a sound knowledge of the Clinical Research Project management profession and personally leads complex, global projects. Familiarity with the essential documents related to clinical studies, medical terminology and routine medical tests and procedures. Familiarity with computerized clinical data collection systems and biomedical statistics is desirable.

Project Management certification is desired. Ability to interact professionally with the principal internal investigators, as well as external academic, for-profit, and non-profit organizations. Ability to work with all levels within the organization from senior management to technicians. Ability to work independently and to perform well under pressure and embrace dynamic environment. Strong organizational and time management skills. Excellent oral & written communication skills with exceptional attention to detail.

Strong computer/technology skills including MS Excel, PowerPoint, and MS Project (or other similar Project Management tools.

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/32087

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