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

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

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, References in collaboration with the faculty PI