Sr. Clinical and Project Development Lead (Center for Cellular Immunotherapy)
- University of Pennsylvania
- Educators and Leadership
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. As an employer Penn has been ranked nationally on many occasions with the most recent award from Forbes who named Penn one of America's Best Employers By State in 2021.
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
Sr. Clinical and Project Development Lead (Center for Cellular Immunotherapy)
Job Profile Title
Associate Director D
Job Description Summary
This candidate must be a proactive problem-solver and have the ability to manage projects, teams and individuals with the goal of keeping timelines and key deliverables on schedule. This candidate must also have a thorough knowledge of Federal Regulations and ICH-GCP guidelines, and a comprehensive understanding of both clinical trial processes and the conduct of clinical studies. The candidate must also have excellent written and oral communication skills, high attention to detail, strong organizational and time management skills, and the ability to work independently and as a team member.
This position is contingent upon funding.
The Sr. Manager, Clinical Development will be responsible for the following:
- Clinical Development
- Provide operational support and clinical trial expertise to enhance and expedite the design, development and implementation of new clinical trials in collaboration with key clinical/scientific stakeholders.
- Develop/design individual clinical protocols and corresponding core documents in collaboration with clinical and scientific experts.
- Shepherd new studies through the clinical development process.
- Develop/facilitate amendments to study protocols and core study documents in response to individual trial needs.
- Assist in the development and maintenance of core document templates for CCI initiated research studies including protocols, consent forms, operational documents/forms, training materials, and study tools/forms.
- Supervisory Responsibilities
- Provide direct supervision and ongoing mentoring/support to a Clinical Development Project Manager.
- Manage the Clinical Development Project Manager's workload/timelines/project prioritization.
- Provide ongoing updates to leadership on staff progress/activities.
- Support the Project Management (DM) Team Supervisor in the development/management of onboarding/training plans for new/ongoing PM staff.
- Provide support/expertise to the PM Team Supervisor and the PM team throughout the onboarding/training process.
- Subject Matter Expert (SME) designee for PM Individual/Team trainings; upon request by Team Supervisors.
- Provide expertise/support/mentorship to all CCI Sponsor Team members on PM processes/procedures.
- Provide coverage/assistance for PM staff when team members are out of office.
- Quality Management/Process Development Responsibilities
- Coordinate/Lead collaborative team meetings with multiple functional groups to support Project Management responsibilities and clinical trial conduct.
- Lead PM team process development/improvement:
- Facilitate the development of data management standard operating procedures (SOPs), guide to daily operations (GDOs), Work Instructions (WIs) and templates/tools.
- Identify project management processes/procedures requiring growth/enhancement or a more formalized infrastructure.
- Perform routine reviews of existing project management processes/procedures; facilitate amendments as required.
- Lead the development/maintenance of template CRF Completion Guidelines (CCGs) for all CCI-Utilized Clinical Data Management Systems; Participate as a core member of the Template CRF Development Teams.
- Work with the PM Supervisor to ensure overall study compliance and quality site management activities for all CCI-initiated projects.
- Project Manager Responsibilities
- Assume the role of Clinical Project Manager for a minimum of 2 CCI-Initiated trials; maintain responsibility for the overall execution of the project from initial development to final closure.
- 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
- Work collaboratively with the Sponsor, Sponsor Program Managers, Data Managers, Monitors, Statisticians, Clinical Investigators, Clinical Cell and Vaccine Production Facility (CVPF), and Translational and Correlative Studies Lab (TCSL) to ensure compliant clinical trial operations.
- Bachelor's Degree with 5-7 years of related 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 including site management and clinical development for complex, high-risk, first-in-human clinical trials required.
- The candidate must possess and have demonstrated the following skills:
- Ability to manage projects independently and keep deliverables on schedule
- Ability to manage individuals including assisting with day-to-day task prioritizations/re-prioritizations to keep projects on schedule
- 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
This position is contingent upon grant funding.
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.
Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.
- Health, Life, and Flexible Spending Accounts: Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family's health and welfare. You can also use flexible spending accounts to pay for eligible health care and dependent care expenses with pre-tax dollars.
- Tuition: Take advantage of Penn's exceptional tuition benefits. You, your spouse, and your dependent children can get tuition assistance here at Penn. Your dependent children are also eligible for tuition assistance at other institutions.
- Retirement: Penn offers generous retirement plans to help you save for your future. Penn's Basic, Matching, and Supplemental retirement plans allow you to save for retirement on a pre-tax or Roth basis. Choose from a wide variety of investment options through TIAA and Vanguard.
- Time Away from Work: Penn provides you with a substantial amount of time away from work during the course of the year. This allows you to relax, take vacations, attend to personal affairs, recover from illness or injury, spend time with family—whatever your personal needs may be.
- Long-Term Care Insurance: In partnership with Genworth Financial, Penn offers faculty and staff (and your eligible family members) long-term care insurance to help you cover some of the costs of long-term care services received at home, in the community or in a nursing facility. If you apply when you're newly hired, you won't have to provide proof of good health or be subject to underwriting requirements. Eligible family members must always provide proof of good health and are subject to underwriting.
- Wellness and Work-life Resources: Penn is committed to supporting our faculty and staff as they balance the competing demands of work and personal life. That's why we offer a wide variety of programs and resources to help you care for your health, your family, and your work-life balance.
- Professional and Personal Development: Penn provides an array of resources to help you advance yourself personally and professionally.
- University Resources: As a member of the Penn community, you have access to a wide range of University resources as well as cultural and recreational activities. Take advantage of the University's libraries and athletic facilities, or visit our arboretum and art galleries. There's always something going on at Penn, whether it's a new exhibit at the Penn Museum, the latest music or theater presentation at the Annenberg Center, or the Penn Relays at Franklin Field to name just a few examples. As a member of the Penn community, you're right in the middle of the excitement—and you and your family can enjoy many of these activities for free.
- Discounts and Special Services: From arts and entertainment to transportation and mortgages, you'll find great deals for University faculty and staff. Not only do Penn arts and cultural centers and museums offer free and discounted admission and memberships to faculty and staff. You can also enjoy substantial savings on other goods and services such as new cars from Ford and General Motors, cellular phone service plans, movie tickets, and admission to theme parks.
- Flexible Work Hours: Flexible work options offer creative approaches for completing work while promoting balance between work and personal commitments. These approaches involve use of non-traditional work hours, locations, and/or job structures.
- Penn Home Ownership Services: Penn offers a forgivable loan for eligible employees interested in buying a home or currently residing in West Philadelphia, which can be used for closing costs or home improvements.
- Adoption Assistance: Penn will reimburse eligible employees on qualified expenses in connection with the legal adoption of an eligible child, such as travel or court fees, for up to two adoptions in your household.
To learn more, please visit: https://www.hr.upenn.edu/PennHR/benefits-pay
To apply, visit https://wd1.myworkdaysite.com/en-US/recruiting/upenn/careers-at-penn/job/Smilow-Center-for-Translational/Sr-Clinical-and-Project-Development-Lead--Center-for-Cellular-Immunotherapy-_JR00040832-1
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