Clinical Data Manager Ii

QUALIFICATIONS:

• Bachelor’s degree in health-related, social science or technical discipline and some graduate level course work in that field required.
• One to two years’ experience in research methods and data management is required
• Experience in research methods and data management applied to clinical research is a plus.
• or equivalent combination of education and experience required
• Must be detail oriented, highly organized, and possess good interpersonal and communication skills required.
• Basic familiarity/experience with electronic data capture and/or other data capture and management systems is required.
• Ability to work effectively in teams is required.
  The University of Rochester is committed to fostering, cultivating, and preserving a culture of equity, diversity, and inclusion to advance the University’s mission to Learn, Discover, Heal, Create - and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion/creed, sex, sexual orientation, citizenship status, or any other status protected by law. This commitment extends to the administration of our policies, admissions, employment, access, and recruitment of candidates from underrepresented populations, veterans, and persons with disabilities consistent with these values and government contractor Affirmative Action obligations.

GENERAL PURPOSE:

The Clinical Data Manager II 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.

RESPONSIBILITIES:

• 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 Good Clinical Practice (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.
  Other duties as assigned