Posted in Other 30+ days ago.
Location: Philadelphia, Pennsylvania
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. As an employer Penn has been ranked nationally on many occasions with the most recent award from Forbes who named Penn one of America's Best Large Employers in 2023.
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.
The Clinical Research Data Manager (CDM) 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 Clinical Data Manager (CDM) will be responsible for performing core data management functions for Phase 1, Penn-Sponsored clinical research studies as follows:
Data Quality/Integrity
Perform study level database training (End User and Sponsor Teams); Create/manage study database training curriculum; Perform re-education/training as needed.
Data Management Review- Develop Study Data Management Plans (DMP); Perform data cleaning and query management; Review raw datasets for trends/patterns, quality concerns/issues, gaps/omissions, etc; Monitor database "health status"/metrics- data entry status, monitoring source data verification and data cleaning performance, missing data, trends/patterns, etc. Work with the appropriate teams to manage data flow, address delays/issues, etc.
Manage primary end user support for the study database.
Investigate/resolve technical issues impacting use of the study database
Data Security
Manage database training documentation
Manage database access/permissions
Database lock and data archiving
Study Database Development
Evaluate new study core documents/amendments to determine data collection/reporting needs and regulatory requirements; Interface with key stakeholders to ensure completeness/accuracy
Create/manage database planning tools and database project timelines; Ensure the database development activities and post-production changes remain on track with anticipated deliverable timelines.
Create/manage CRF Completion Guidelines (CCGs) and data entry/reporting expectations.
Perform validation activities (relative to project requirements and applicable FDA regulatory guidelines)- Includes Metadata, Peer Review, UAT, etc.
Database Development:
Lead Study case report form (CRF) development and maintenance activities
Facilitate CRF review, validation and approvals.
Manage database deployment activities.
Data Extraction/Reporting
Provide input into study and project level data analysis plans.
Creating/maintaining reporting tools to support study needs.
Report generation/execution- including, but not limited to, reports for routine monitoring visits, study management, regulatory reporting, collaborator reporting, etc.
Participate in the preparation, visualization, and presentation of study data/reports for publication/presentation and/or statistical analysis.
Process Development/Quality Improvement
Assist in developing/implementing process changes and system improvements.
Provide input on templates/tools, data standards, etc.
SOP development and maintenance for business process needs
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.
This position is contingent upon funding.
Qualifications
Bachelor's degree required and 3-5 years of related experience or equivalent combination of education and experience.
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