Senior Clinical Project Manager B
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.
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 Senior Clinical Trial Project Manager will independently manage multiple Phase I-Phase II Penn-Sponsored clinical research studies in order to ensure execution of clinical research and oversee clinical studies from concept to final close, including study start-up activities, study monitoring activities, data collection, project maintenance and project close-out activities.
The Sr. Clinical Project Manager will be responsible for the cross-functional team’s compliance with the project Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) / International Conference on Harmonization (ICH) guidelines and other applicable regulations. The Sr. Clinical Project Manager is responsible for the overall execution of the project and may be the principal liaison to ensure effective and timely communication of project progress, issues, and plans for resolution of those issues.
- Develop clear and measurable project management plans; Define timelines, milestones, and limitations to project
- staff and study sites.
- Monitor project status and timelines
- Manage clinical projects/programs, including deliverables from all functional areas and vendors in accordance with contractual timelines and sponsor specifications.
- Establish project metrics and project schedules with client representatives. Provide at least monthly project updates.
- Facilitate case report form development, review, approval, and finalization with the Data Management Team
- Development of Manual of Procedures (as applicable) and site study binders including all required Sponsor Forms/Templates
- Support clinical development of protocol/consent form documents
- Facilitate local regulatory review committee approvals as required for multisite trials
- Coordinate site initiation visit/site training
- Review/process protocol exceptions/deviations
- Prepare and process DSMB Reports; Organize and coordinate DSMB Meetings
- Reporting of study progress and subject statuses; provide IND summary information for the IND annual report
- Review/report the status of case report form completion and data query resolution
- Develop and provide study and/or protocol amendment training to sites
- Manage/maintain the Sponsor Trial Master Files for each project/site
- Participate in SOP development.
A Bachelor’s degree and 5 years to 7 years of experience or equivalent combination of education and experience required.
Knowledge of FDA regulations and GCP-ICH guidelines; and comprehensive understanding of clinical trials processes and the conduct of clinical research studies.
Previous Project Management experience preferred. The candidate must possess and have demonstrated the following skills:
- Ability to manage projects independently
- Strong problem-solving and organizational skills
- High attention to detail
- Demonstrated ability to manage multiple tasks simultaneously and complete work within allocated time frames
- Excellent oral and written communication skills
- Excellent organizational and time management skills
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.