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    Senior Clinical Trial Project Manager - Philadelphia, United States - Perelman School of Medicine University of Pennsylvania

    Perelman School of Medicine University of Pennsylvania
    Perelman School of Medicine University of Pennsylvania Philadelphia, United States

    1 week ago

    Default job background
    Full time
    Description

    Description

    Job Responsibilities Include:

  • Develops clear and measurable project management plans; Defines 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.
  • Establishes project metrics and project schedules with client representatives. Provides at least monthly project updates.
  • Facilitate case report form development, review, approval, and finalization with the Data Management Team
  • Development of Manual of Procedures and site study binder 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
  • Coordination of 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.

    • The candidate must be a proactive problem-solver with the ability to critically evaluate and manage timelines and key deliverables. This includes coordination with the clinical team, authoring manual of procedures for the conduct of the trial, attending and participating in trial-kick-off meetings (requiring limited travel to participating sites), and providing technical leadership and scheduling for the team to ensure deliverables. 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.

    Salary: The job pay range encompasses the full range of employees from new hires to the salaries of Penn employees with many years of experience and seniority and is not a precise indicator of salaries of new hires when looking at the top end. Based on what we pay employees coming into this position our pay range is $80,000-$85,000, based on education and experience above the minimum qualifications.

    Qualifications

  • Bachelor's Degree with 5-7 years of related experience or equivalent combination of education and experience is 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 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

    • Job Location - City, State

    Philadelphia, Pennsylvania

    Department / School

    Perelman School of Medicine

    Pay Range

    $61, $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.

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