Sr. Data Management Operations Specialist (Dept. for Center for Cellular Immunotherapy)

Job description



Sr. Data Management Operations Specialist (Dept. for Center for Cellular Immunotherapy)

University Overview

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.

Posted Job Title
Sr. Data Management Operations Specialist (Dept. for Center for Cellular Immunotherapy)

Job Profile Title
Manager Research Project B

Job Description Summary
The Sr. Data Management Operations Specialist will be responsible for the following:

  • Supervisory Responsibilities
    o Recruit, hire, and supervise a full-time Data Coordinator (DC).
    o Responsible for onboarding and ongoing training of the Data Coordinator, including a customized onboarding/training plan.
    o Manage DC workload/timelines/project prioritization
    o Provide coverage for DC staff when team member is out of office.
    o Provide ongoing updates to leadership on staff progress/activities
  • Training/Mentorship
    o Develop/maintain template onboarding documentation including competency checklists for the Data Management (DM) Team.
    o Support the Data Management (DM) Team Supervisor in the development/management of onboarding/training plans for new/ongoing DM staff; Provide support/expertise to the DM Team Supervisor in the onboarding process.
    o Serve as an onboarding guide/resource for all new ClinOps Team members through the introductory period to allow them to more seamlessly integrate into the ClinOps Team; Responsibilities include providing support/mentorship, facilitating knowledge-sharing, providing specialized tips/techniques, etc.
    o Subject Matter Expert (SME) designee for DM Individual/Team trainings; upon request by Team Supervisors.
    o Lead PennCTMS/Velos Database Training and corresponding Velos process training for new Sponsor/Site Team members; Delegate to other SME with oversight at their discretion.
    o Provide technical expertise/support/mentorship to CCI Sponsor Team members on DM processes/procedures and the PennCTMS/Velos Database System.
    o Identify, coordinate and facilitate team building activities.
  • Data Quality Management/Process Development Responsibilities
    o Lead the CCI PennCTMS Template Case Report Form Development Team; Coordinate/Lead collaborative team meetings with multiple functional groups.
    o Primary liaison with the SOM OCR/DART teams regarding PennCTMS/Velos system issues/bugs and potential system improvements.
    o Lead DM 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 data management processes/procedures requiring growth/enhancement or a more formalized infrastructure.
    Perform routine reviews of existing data management processes/procedures; facilitate amendments as required.
    o Work with the DM Supervisor to ensure overall data quality/integrity/security for all CCI-initiated projects.
  • Data Manager Responsibilities
    o Assume the role of Clinical Data Manager for 2-3 trials and will be responsible for providing clinical data management support for assigned Center for Cellular Immunotherapies (CCI)-Initiated protocols, including all tasks associated with study data management necessary for DSMB meetings/reports, IND Annual Reports, monthly reports, monitoring visit preparation/follow-up and interim data reporting/database locks, as well as ad hoc queries.
    o Independently create CRFs (Case Report Forms) in electronic database systems to collect required data from all clinical trials. The Clinical Data Manager ensures data collection is accurate, capturing all activities required by the protocol including, but not limited to all data groups such as: enrollment information, clinical labs/procedures, demographics, infusion information, response data, etc. The CDM must be able to understand the needs of complex, high-risk, gene and immunotherapy clinical research protocols, and accurately build case report forms that capture required research information to ensure primary and secondary endpoints are documented.
    o Continually evaluate the CRFs for required modifications due to the dynamic nature of this research. Amend CRFs in response to protocol amendments/changes in study endpoints.
    o Assist in the development and review of study-specific data management documents, including Data Management Plans and Case Report Form Completion Guidelines, as well as sponsor data management standard operating procedures.
    o Develop and conduct Investigator/Study Team training on the Clinical Database, CRFs, and data entry requirements.
    o Provide input into study and project level data analysis plans.
    o Participate in the preparation and presentation of study data/reports.
    o Facilitate and conduct data cleaning activities including data review and query generation for assigned protocols
    o Produce and provide metrics on data entry/processing to the Project Manager.
    o Assist in implementing process changes and system improvements.
    o Coordinate the archiving of study data and study related documents for assigned protocols.
    o Work collaboratively with the Sponsor/Sponsor Program Managers, Project Managers, Monitors, Statisticians, Clinical Investigators, Clinical Cell and Vaccine Production Facility (CVPF), and Translational and Correlative Studies Lab (TCSL) to ensure required data is captured.
    *As Needed

    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 communication and presentation skills, high attention to detail, excellent organizational and time management skills, and the ability to work independently and as a team member.

    Job Description

    The Sr. Data Management Operations Specialist will be responsible for the following:
    • Supervisory Responsibilities
      • Recruit, hire, and supervise a full-time Data Coordinator (DC).
      • Responsible for onboarding and ongoing training of the Data Coordinator, including a customized onboarding/training plan.
      • Manage DC workload/timelines/project prioritization
      • Provide coverage for DC staff when team member is out of office.
      • Provide ongoing updates to leadership on staff progress/activities
    • Training/Mentorship
      • Develop/maintain template onboarding documentation including competency checklists for the Data Management (DM) Team.
      • Support the Data Management (DM) Team Supervisor in the development/management of onboarding/training plans for new/ongoing DM staff; Provide support/expertise to the DM Team Supervisor in the onboarding process.
      • Serve as an onboarding guide/resource for all new ClinOps Team members through the introductory period to allow them to more seamlessly integrate into the ClinOps Team; Responsibilities include providing support/mentorship, facilitating knowledge-sharing, providing specialized tips/techniques, etc.
      • Subject Matter Expert (SME) designee for DM Individual/Team trainings; upon request by Team Supervisors.
      • Lead PennCTMS/Velos Database Training and corresponding Velos process training for new Sponsor/Site Team members; Delegate to other SME with oversight at their discretion.
      • Provide technical expertise/support/mentorship to CCI Sponsor Team members on DM processes/procedures and the PennCTMS/Velos Database System.
      • Identify, coordinate and facilitate team building activities.
    • Data Quality Management/Process Development Responsibilities
      • Lead the CCI PennCTMS Template Case Report Form Development Team; Coordinate/Lead collaborative team meetings with multiple functional groups.
      • Primary liaison with the SOM OCR/DART teams regarding PennCTMS/Velos system issues/bugs and potential system improvements.
      • Lead DM 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 data management processes/procedures requiring growth/enhancement or a more formalized infrastructure.
        • Perform routine reviews of existing data management processes/procedures; facilitate amendments as required.
      • Work with the DM Supervisor to ensure overall data quality/integrity/security for all CCI-initiated projects.
    • Data Manager Responsibilities
      • Assume the role of Clinical Data Manager for 2-3 trials and will be responsible for providing clinical data management support for assigned Center for Cellular Immunotherapies (CCI)-Initiated protocols, including all tasks associated with study data management necessary for DSMB meetings/reports, IND Annual Reports, monthly reports, monitoring visit preparation/follow-up and interim data reporting/database locks, as well as ad hoc queries.
      • Independently create CRFs (Case Report Forms) in electronic database systems to collect required data from all clinical trials. The Clinical Data Manager ensures data collection is accurate, capturing all activities required by the protocol including, but not limited to all data groups such as: enrollment information, clinical labs/procedures, demographics, infusion information, response data, etc. The CDM must be able to understand the needs of complex, high-risk, gene and immunotherapy clinical research protocols, and accurately build case report forms that capture required research information to ensure primary and secondary endpoints are documented.
      • Continually evaluate the CRFs for required modifications due to the dynamic nature of this research. Amend CRFs in response to protocol amendments/changes in study endpoints.
      • Assist in the development and review of study-specific data management documents, including Data Management Plans and Case Report Form Completion Guidelines, as well as sponsor data management standard operating procedures.
      • Develop and conduct Investigator/Study Team training on the Clinical Database, CRFs, and data entry requirements.
      • Provide input into study and project level data analysis plans.
      • Participate in the preparation and presentation of study data/reports.
      • Facilitate and conduct data cleaning activities including data review and query generation for assigned protocols
      • Produce and provide metrics on data entry/processing to the Project Manager.
      • Assist in implementing process changes and system improvements.
      • Coordinate the archiving of study data and study related documents for assigned protocols.
      • Work collaboratively with the Sponsor/Sponsor Program Managers, Project Managers, Monitors, Statisticians, Clinical Investigators, Clinical Cell and Vaccine Production Facility (CVPF), and Translational and Correlative Studies Lab (TCSL) to ensure required data is captured.

    *As Needed

    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 communication and presentation skills, high attention to detail, excellent organizational and time management skills, and the ability to work independently and as a team member.

    QUALIFICATIONS:
    • Bachelor's Degree with 5-7 years of related experience or Master's 3-5 years 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 Data Management experience in database development and clinical data management for complex, high-risk, multisite 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 funding.

    Working Conditions
    Office, library, computer room

    Physical Effort
    Typically sitting at a desk or table; Occasional lifting 25 lb. or less; Typically standing or walking

    Job Location - City, State
    Philadelphia, Pennsylvania

    Department / School
    Perelman School of Medicine

    Pay Range
    $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.

    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.



    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-Data-Management-Operations-Specialist--Dept-for-Center-for-Cellular-Immunotherapy-_JR00033932-2





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    Job No:
    Posted: 6/8/2021
    Application Due: 6/8/2033
    Work Type: Full Time
    Salary: