Responsible for the management of the Data Management function, and other subordinate data management employees, project management, and the creation, updating, maintenance and validation of clinical study databases and for the provision of computerized reports of these data.
Assumes the responsibility for the overall management of clinical trial data management objectives and deliverables through the management of subordinates, and the review, computerization, cleaning and auditing of clinical data and databases in compliance with standard operating procedures, industry and regulatory agency guidelines.
Provide data management / data entry / verification / validation / quality control of data collected for worldwide Clinical Trials consistent with applicable regulations, guidelines and policies
Understand all relevant data standard including FDA Safety & Innovation Act of 2012 (FDASIA), CDISC / CDASH compliant data standards
Familiarity with Clinical Data Management industry standards (i.e. CDASH, etc.)
Adheres to current Good Clinical Data Management Practices Guidelines (GCDMP)
Must have at least 3 years of supervisory experience managing data management subordinates
Must have relevant experience developing and maintenance of clinical data management programs and databases
Minimum 5 years in relevant work
BS degree in related area or equivalent experience.
Prior people management and clinical data management experience required
Certificates and Licenses:
Certified Data management certification, or other training a licenses in data management are a plus.