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

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 the 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 journals.

• 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.
• Act as liaison 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 online clinical trial management databases to monitor and analyze clinical trial study requirements and data analyses.
• 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.
• Ensure 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).
• Review emerging clinical data and trends in cardiac surgery.
• Design and analyze complex surgical outcomes databases.
• Integrate database systems with statistical 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 health services research and quality analyses; create analytic files; develop standard statistical algorithms for hypothesis testing.
• Supervise students, Penn Surgery residents, fellows, lab members and mentor them in design of database systems.
• Prepare sections of NIH grant application and manuscripts specific to Significance, Statistical Methods, Analyses, Findings, Conclusions, References in collaboration with the faculty PI.

• Master of Science and 3 to 5 years of experience or equivalent combination of education and experience.
• 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.

Philadelphia, Pennsylvania

Perelman School of Medicine

$66,000.00 - $81,441.00 Annual Rate

The University of Pennsylvania is an equal opportunity employer. Candidates are considered for employment without regard to race, color, sex, sexual orientation, religion, creed, national origin (including shared ancestry or ethnic characteristics), citizenship status, age, disability, veteran status or any class protected under applicable federal, state or local law.

Background checks may be required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.