Project Manager B: Protocol Development, Clinical Statistics and Data Analyses

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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. Posted Job Title Project Manager B: Protocol Development, Clinical Statistics and Data Analyses Job Profile Title Manager Research Project B Job Description Summary Responsible for both strategic planning and day to day management of complex and broad range of projects conducted with collaborators both internal and external to University. Take leadership role in developing study protocols, writing grants, managing the detailed operations of projects, analyzing qualitative and quantitative data, cultivating close relationships with community partner organizations, and drafting/editing manuscripts for submission to peer-reviewed journal. Job Description Job Responsibilities Investigator Initiated Protocol/Study Specific - Collaborate with Cardiac Surgeon/PIs to define study objectives and requirements on investigator initiated clinical trials (IDE and IND) - Design and draft detailed investigator initiated protocols (including eligibility, screening, study assessments) that comply with regulatory standards - Design and draft informed patient consent forms specific to each investigator initiated protocol - Liaisons with statisticians, Surgeon PIs, co-investigators, clinical trials support staff on all trials - Expand non-scientific sections of protocols with minimal oversight - Review and revise investigator initiated protocols based on feedback from federal, state and local regulatory authorities. Prepare annual reports for regulatory authorities. - Provide ongoing training and study start-up for investigator initiated studies - Develop study specific case report forms (CRF) with statistical input. Standardize data type specifications to align with Electronic Data Capture (EDC) requirements and clinical trial objectives. - Develop on-line clinical trial management data bases to monitor and analyze clinical trial study requirements and data analyses Study Start-up for Investigator Initiated Studies - Independently prepare and negotiate clinical trials budgets with external sponsors - Conduct study qualification visits for multi-site studies - Conduct study initiation visits for all sites (including UPHS facilities) - Develop detailed data transfer specifications for acquiring external data transfer from participating sites Study Monitoring/Compliance for Investigator Initiated Studies - Responsible for ensuring timely and accurate completion of Serious Adverse Events (SAEs) and Adverse Events (AEs) at participating sites (UPHS and external locations) - Monitor participating sites for protocol compliance and deviations with reports to regulatory authorities as required - Issue and resolve queries from various data sources (medical coding, medical history, adverse events, procedures and medical devices) Statistical and Study Related Analyses - Review of emerging clinical data and trends in cardiac surgery - Design complex surgical outcomes databases - Analyze complex surgical outcomes databases - Integrate database systems with statistics programs using SAS, Stata and other tools - Perform complex programming using large databases of more than 1 million records and nationwide hospital data sets for use in health services research and quality analyses. Create analytic files. Develop the standard statistical algorithms for hypothesis testing - Supervise students, Penn Surgery residents, fellows, lab members and mentor them in design of data base systems. NIH Grant and Manuscripts - Technical Writing - Prepare sections of NIH grant application and manuscripts specific to Significance, Statistical Methods, Analyses, Findings, Conclusions, Re

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