Responsibilities:
Services rendered will adhere to applicable Pharmaceutical SOPs, WIs, policies, local regulatory requirements, ICH-GCP, etc.
Creation of ADaM datasets based on current ADaM standards.
Creation of Tables, Listings and Figures following Janssen specifications.
Creation of Subject Narratives following Janssen templates too support Narrative development.
Creation of other ancillary data streams including (but not limited to) clinical registry reporting files ( , EudraCT), Bioresearch monitoring reports (BIMO).
QC of all programmed output.
Creation and/or maintenance of detailed specification documentation.
Development and validation of electronic submission packages that comply with submission requirements from FDA, EMEA and other regulatory agencies as needed.
Includes support for standalone studies as well as integration of data across studi...