University of Rochester Information Analyst II in Rochester, New York
Full Time 40 hours Grade 052 Neuro-Ctr Human Exp Ther/CTCC
8 AM-5 PM; OCC WKENDS
The Clinical Data Manager II serves as a clinical data manager, who 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.
Under general guidance and with considerable latitude for the exercise of independent judgment and initiative:
- 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).
- 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.
- Effectively manages assigned projects by adhering to established timelines and deliverables.
- Creates and maintains essential documents for the Trial Master File to ensure compliance to GCP standards and applicable regulatory requirements.
- Performs 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.
- Follows operating procedures and guidelines for clinical data management activities; may lead efforts to identify new procedures and/or tools for clinical data management activities.
- Conducts protocol-specific data management training at Investigator meetings and throughout the course of the study.
- May oversee the activities of junior information analysts.
Bachelor's degree in health-related, social science or technical discipline required. One to two years’ experience in research methods and data management is required. Equivalent combination of education and experience may substitute. Must be detail oriented, highly organized, and possess good interpersonal and communication skills. The ability to work effectively in teams is required. Basic familiarity/experience with electronic data capture and/or other data capture and management systems is required. Experience in research methods and data management applied to clinical research is a plus.
EOE Minorities/Females/Protected Veterans/Disabled
Job Title: Information Analyst II
Location: School of Medicine & Dentistry
Job ID: 211271
Full/Part Time: Full-Time