Job Description Summary

The Project Manager will manage the day-to-day operations of data coordinating center for clinical research studies with various funding sponsors (government, industry, foundation). The responsibilities of the Project Manager will range from planning and developing guidance materials, data collection methods, and tracking systems for study operations to monitoring external site performance and study close-out procedures. The Project Manager will be responsible for ensuring regulatory compliance of all research projects. The Project Manager will lead the organizational planning for electronic data capture systems (EDCs) and oversee the data collection and data quality. The Project Manager will also support the Director of the Data Coordinating Center on the grant application, manuscript development and presentation of study findings.

The ideal candidate for this position will have the ability to manage a dynamic pace and varied research-related responsibilities in accordance with University of Pennsylvania, GCP, FDA, and other governing-entity guidelines.

Job Responsibilities

Operations Management

• Develop and maintain study documents including protocols, manuals of operations and procedures, data collection forms, training materials, and study/data presentation materials in various formats.
• Lead or facilitate communications with various departments and external organizations, such as IDS, CRCU, collaborating academic medical centers, etc. as needed for study operations.
• Lead the training and oversee implementation of study procedures of external study sites.
• Oversee all research activities including recruiting, screening, enrolling and data collection and transmission for assigned research studies.
• Support the director and biostatisticians for the successful operation of the data coordinating center.

Regulatory Management

• Implement regulatory plans for multi-site studies, effectively assigning team members as needed for preparation of regulatory documentation.
• Prepare and track all regulatory submissions for assigned studies including initial reviews, modifications, continuing reviews, deviations, and study close-outs.
• Ensure regulatory compliance by all sites relying on Penn's IRB as the Central IRB and overseeing regulatory compliance by sites operating under their own institution's IRB, if applicable.
• Prepare and submit all required documentation and reports for SAEs and protocol deviations per UPenn, sponsor, FDA and other applicable regulating entity requirements.

Data Management

• Lead the organizational planning for electronic data capture systems (EDCs) and track the build-out and maintenance of the EDCs for each assigned project ensuring data is collected and stored in accordance with HIPAA and University guidelines.
• Oversee data entry, tracking data quality and completeness, and monitoring completion of study procedures at internal and external study sites.
• Communicate with clinical sites for the data queries.
• Coordinate clinical site personnel for the data collection using data systems (e.g., Redcap).
• Review interim and final data reports to identify and address missing data and data discrepancies.
• Prepare and maintain data reports for progress reporting to investigators, funding sponsor, collaboration institutions, and community partners.

Additional Responsibilities

• Coordinate and facilitate project meetings and data safety monitoring committee (DSMC) meetings including setting agendas, reserving conference rooms or sending virtual meeting information, preparation of meeting materials/notebooks.
• Supervise trainees/students and study canvassers and manage workload and performance.
• Adhere to all University of Pennsylvania, GCP, and FDA guidelines.
• Perform additional duties as need to ensure success of all research projects.

Qualifications

• Bachelor of Science and 3 to 5 years of experience or equivalent combination of education and experience is required.

Position is contingent upon continued funding.