University of Rochester Clinical Data Manager, Senior - 213786 in Rochester, New York
Clinical Data Manager, Senior Job ID 213786Location School of Medicine & Dentistry Full/Part Time Full-Time Favorite Job Regular/Temporary Regular Opening
Full Time 40 hours Grade 054 Neuro-Ctr Health & Tech/CTCCSchedule
8 AM-5 PM; OCC WKENDResponsibilities
The Senior Clinical Data Manager is responsible for the clinical data management (CDM) activities for the entire life cycle of multiple clinical trials in Phases I-III, from protocol development through database lock. Directs and oversees the activities of subordinate staff on study teams. Interacts with Principal Investigators and senior management.
Under general guidance and with considerable latitude for the exercise of independent judgment and initiative:
Consults with Principal Investigator and Senior Management concerning the studies and projects to be conducted and the best method for securing and presenting information. Evaluates and becomes familiar with research protocols and objectives. Coordinates study start-up activities, including review and sign off of source documents for the electronic data base, source completion guidelines, data validation (edit check) specifications, and the data management plan (DMP).
Devises methods for complex search strategies and collection of information, often using statistical methods and computer programming and analysis. Conducts ongoing data review and cleaning, oversees data entry timeliness and query management with investigative sites to ensure data quality, reconciles serious adverse events and vendor data against clinical database.
Creates and maintains standard operating procedures and guidelines for clinical data management activities; may lead efforts to identify new procedures and/or tools for clinical data management activities.
Effectively manages assigned projects by adhering to established timelines and deliverables.
Ensures proper auto and manual coding of study adverse events, medical history, and concomitant medications.
Oversees locking of the database at study completion and works with lead programmers to ensure databases are well validated and ready for data transfer and/or statistical analyses.
Directs the activities of subordinate staff in the conduct of gathering, compiling and analyzing information. Works with faculty, administrative staff and community groups to establish plans and procedures for the conduct of studies and clarify problems as they arise.
Conducts protocol-specific data management training at Investigator meetings and throughout the course of the study.
Bachelor’s degree with major course work in social or technical field, and Master’s degree in Library Science, Information Science or related field desirable, and 4-5 years’ experience in the analysis and dissemination of information plus supervisory experience; or an equivalent combination of education and experience.How To Apply
All applicants must apply online.
EOE Minorities/Females/Protected Veterans/Disabled