Sr. Clinical Trial Project Manager (Center for Cellular Immunotherapy)

Description

The Sr. Clinical Trials Project Manager position works within the Center for Cellular Immunotherapies Clinical Operations Team.

The primary mission of the Clinical Operations Team is to manage and optimize the clinical research infrastructure necessary for bringing these novel / personalized cell and gene therapies to patients.

The key objectives of the Clinical Operations Team include :

Supporting the translation of first-in-human investigational cell and gene therapy products from the bench to bedside.

Managing / accelerating the clinical trial development and new study activation pathways.

Establishing internal and external collaborative partnerships.

Establishing / maintaining the infrastructure required to standardize and optimize clinical trial development and execution;

and ensuring ongoing oversight / compliance.

Developing / refining standardized processes, procedures, and templates / tools to align with the changing regulatory landscape and new scientific innovation.

Ensuring the generation of high-quality, reliable and statistically sound clinical data that can be used for reporting, publication, endpoint analysis and further product development.

Identifying / implementing new technology / systems required to enhance clinical research operations.

In this role, the Sr Clinical Trial Project Manager will independently manage a portfolio of Phase I Penn-Sponsored clinical research studies.

The Sr. Clinical Project Manager is responsible for the overall execution and management of their assigned projects, from initial study start-up to study close / database lock.

Core functional responsibilities of the Sr. Clinical Trials Project Manager position include :

Overall Project Planning and Implementation :

Monitor project status / timelines; Ensure all required milestones are met and that the project remains on schedule.

Provide input / expertise on core study documents.

Develop / maintain required study manuals

Manage and execute all study start-up activities; Includes coordinating / hosting the site initiation visit (SIV)

Establish / maintain the Sponsor Trial Master File (TMF)

DSMB Coordination / Management- includes development / maintenance of all required DSMB documentation, adherence to the DSMB Charter, organization / scheduling / hosting of the DSMB meeting, DSMB reporting, etc.

Qualification / oversight of 3rd party sponsor vendors (as applicable)

Work collaboratively with the Data Management team to develop a compliant study database and supportive data management documentation;

PM focus on content expertise, study application, and end-user experience.

Site / Study Management

Provide seamless oversight of ongoing study activities; Support site management activities

Facilitate required updates / reporting to sponsor teams and 3rd party collaborators; Ensure adherence to data sharing / reporting requirements in contractual agreements

Support sponsor regulatory reporting requirements

Work collaboratively with the monitoring team to manage / address compliance concerns, execute training, triage exception requests / deviation reports, etc.

Develop / facilitate additional training activities including training on amendments to core study documents

Perform ongoing data management review; Ensure site adherence with data entry timelines / expectations and overall data quality / completeness

Work collaboratively with the Data Management team to plan / execute database amendments

Support data review / reporting for analysis, presentation, publications, etc.

Departmental / Team Responsibilities :

Contribute expertise / knowledge to the development / maintenance of project management policies / procedures, templates / tools, etc.

Support training / mentoring of new Clinical Operations team members

Other duties as assigned

Given the fast-pace nature of this role and the complexity of the research, eligible candidates must possess / demonstrate the following competencies :

Ability to manage projects independently

Strong analytical and problem-solving skills

Excellent organizational and time management skills

High attention to detail; demonstrated ability to multi-task

Excellent oral and written communication skills

This candidate must also have a thorough knowledge of Federal Regulations and ICH-GCP guidelines, and a comprehensive understanding of clinical trial processes, and the conduct of clinical studies.

Reference Information : The salary range included in the job posting encompasses the full range of employees at the University of Pennsylvania, with varying levels / years of experience, seniority, functional responsibilities, etc.

Therefore it cannot be used as a precise indicator of the salary range for this position. The actual salary offered for this position will be determined by the Compensation Office in the Division of Human Resources and will be evaluated based on the qualifications of each individual candidate and internal equity.

Job Location : Hybrid Eligible- This position is eligible for a hybrid work schedule with a work week divided between working onsite and working remotely.

Qualifications

• Bachelor’s Degree with 5-7 years of related experience; or combination of equivalent education / experience.
• 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 strongly recommended. Qualified candidates 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

This position is contingent upon grant funding.

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$61,046.00 - $81,441.00 Annual Rate

Salary offers are made based on the candidate’s qualifications, experience, skills, and education as they directly relate to the requirements of the position, as well as internal and market factors and grade profile.

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.

University Benefits

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.