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

    University Of Pennsylvania
    5+ years
    Not Disclosed
    Remote - Europe
    10 Nov. 14, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    University Overview

    The University of Pennsylvania (Penn), the largest private employer in Philadelphia, stands as a world-renowned leader in education, research, and innovation. Consistently ranked among the top 10 universities in the U.S. News & World Report survey, Penn offers a unique, interdisciplinary approach to learning across its 12 highly regarded schools. The university is known for its excellent working environment and was named one of America’s Best Large Employers by Forbes in 2023. Situated in Philadelphia, Penn provides easy access to a wide range of educational, cultural, and recreational activities within its vibrant urban campus.

    Job Title: Sr. Clinical Trial Project Manager (Center for Cellular Immunotherapy)
    Job Profile: Manager Research Project B
    Location: Philadelphia, PA
    Department: Perelman School of Medicine
    Salary: $61,046 - $81,441 Annually
    Hybrid Work: Eligible

    Job Description Summary
    The Sr. Clinical Trials Project Manager at the Center for Cellular Immunotherapies (CCI) will play a pivotal role in accelerating the development of innovative cell and gene therapies. Reporting to Dr. Carl June, the position supports the transition of cutting-edge immunotherapies from research to clinical trials. The role requires expertise in managing clinical research operations, ensuring compliance, and collaborating with internal and external stakeholders to drive the success of personalized therapies.

    Key Responsibilities:

    • Oversee clinical trial execution from start-up to study close, ensuring adherence to timelines and regulatory compliance.
    • Develop and maintain project plans, study manuals, and ensure the proper documentation of trial activities.
    • Manage study start-up, including hosting site initiation visits (SIV) and maintaining the Sponsor Trial Master File (TMF).
    • Facilitate the development and scheduling of Data Safety Monitoring Board (DSMB) meetings and maintain required documentation.
    • Coordinate with third-party vendors and collaborate with data management teams to ensure the integrity and quality of clinical data.
    • Support regulatory reporting, compliance, and site management activities, ensuring adherence to data-sharing and reporting requirements.
    • Contribute to the development of internal policies and training programs to maintain high standards in clinical trial management.

    Qualifications:

    • Bachelor’s Degree with 5-7 years of related experience; or equivalent education/experience.
    • Strong knowledge of FDA regulations, GCP-ICH guidelines, and clinical trial processes.
    • Proven project management experience with the ability to independently manage multiple tasks.
    • Excellent problem-solving, organizational, and communication skills.
    • Experience working in a fast-paced, complex research environment.

    Benefits:

    • Comprehensive health and wellness programs.
    • Tuition assistance for employees and their families.
    • Generous retirement plans and flexible work options.
    • Access to cultural and recreational activities at the University.
    • Professional development resources and employee discounts.

    Special Requirements:

    • Background check required upon a conditional job offer.

    Affirmative Action Statement
    Penn adheres to a policy that prohibits discrimination based on race, sex, sexual orientation, gender identity, disability, and other legally protected categories.

    This position offers an excellent opportunity for individuals passionate about cutting-edge research and clinical trials in the field of immunotherapy.

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