Data Management Team Supervisor, Clinical Operations

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 Pennâ™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

Job Profile Title

Job Description Summary

Job Description

• Supervisory Responsibilities
  • Recruit, hire, and supervise DM Team staff; including performance management activities, annual appraisals, etc.
  • Responsible for onboarding/training of DM staff, with support from the Sr. Clinical Research Data Specialist (SCRDS).   Customize onboarding/training plan for each new team member.  Perform re-education/training as needed.  Work collaboratively with the SCRDS to perform cross-team training/onboarding support.
  • Manage DM workload/timelines/project prioritization
  • Work collaboratively with the SCRDS to provide ongoing mentorship/support for the DM staff on a day-to-day basis; trouble-shoot operational issues/concerns, and escalate as needed.
  • Review/approve all database build/amendment/closeout planning tools prior to team implementation and provide ongoing guidance/assistance to ensure timely completion of deliverables/overall project.
  • Meet with each direct report at a minimum of twice monthly
  • Attend study team meetings (i.e. PM/DM, PM/DM/Monitor)*
  • Attend protocol related trainings (Database Build/Amendments, SIVs, Protocol amendment, IP Handling, Lab Manual, etc.)*
  • Coordinate/Lead collaborative team meetings with multiple functional groups.
  • Provide ongoing updates to leadership on staff progress/activities and data management deadlines/deliverables.
  • Provide coverage for DM staff when team members are out of office.

• Data Quality Management/Process Development Responsibilities
  • Assist the SCRDS in maintaining overall data quality/integrity/security for all CCI-initiated projects.
  • Assist the SCRDS with developing, enhancing and maintaining compliant Data Management business processes/procedures, documentation, workflows/template forms, etc.   
  • Assist the SCRDS and CCI Clinical Operations Leadership team in identifying areas requiring growth/development, enhancement or formalized infrastructure specific to ClinOps data management practices/procedures.
  • Provide support to the SCRDS on other data management related functions as needed.

• 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.  

This position is contingent upon funding.

QUALIFICATIONS:

• Bachelorâ™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 Data Management experience providing clinical data management support for complex, high-risk, multisite clinical trials required.
• The candidate must possess and have demonstrated the following skills:

• Ability to manage projects independently and on schedule
• Ability to manage teams 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
• Excellent organizational and time management skills

Working Conditions
Office, library, computer room

Physical Effort
Typically sitting at a desk or table

Job Location - City, State

Department / School

Pay Range

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.