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

Job Details

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

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.

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 Responsibilities

• 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
• Design and draft informed patient consent forms
• Liaisons with statisticians, Surgeon PIs, co-investigators, clinical trials support staff on all trials
• Develop study specific case report forms (CRF) with statistical input
• Independently prepare and negotiate clinical trials budgets with external sponsors
• Responsible for ensuring timely and accurate completion of Serious Adverse Events (SAEs) and Adverse Events (AEs)
• 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
• Prepare sections of NIH grant application and manuscripts

Qualifications

• Master of Science and 3 to 5 years of experience or equivalent combination of education and experience is required.
• Experience with clinical research protocols essential
• Familiarity with regulatory processes (GCP) for clinical protocols and informed consent development

This position is contingent upon grant funding.