Senior Manager, Clinical Data and Reporting Standards (Remote) – Nigeria
Expected set of responsibilities
The Ranking director, Clinical Information and Announcing Guidelines (CDARS) proactively partakes in the advancement of information and revealing principles on the side of AbbVie’s arrangement of clinical preliminaries and guaranteeing AbbVie’s conformance to CDISC norms and industry best practices. This job carries out the procedure and structure for administration of norms as set by the Head and Partner Overseers of CDARS, and effectively participates in sending of cutting edge cycle and innovation.
Norms Advancement obligations include:
Driving or partaking in a cross-practical group of educated authorities to characterize something like one of the accompanying kinds of principles inside the relegated helpful area: Data Assortment
Information Audit Rules
SDTM planning
ADM planning and deduction
Study-level tables, postings, or figures.
Item level security examination shows
Guaranteeing every standard is obviously characterized, with proper documentation of significant suppositions and choices connected with its utilization to help pipeline exercises.
Support teaching the association on the appropriate utilization of guidelines in pipeline exercises by adding to the improvement of preparing materials.
Impart continuous standard improvement exercises across the association.
Pipeline obligations include:
Giving criticism on CRF plan and SDTM datasets to guarantee information are gathered and addressed in a way that help administrative prerequisites to follow CDISC principles (CDASH, SDTM and ADaM) and AbbVie standard expansions to CDISC.
Audit and give criticism on SDTM Preliminary Plan Spaces
Administer the making of SDTM define.xml, explained CRF and Clinical Review Information Commentator’s Aides for both FDA and PMDA entries.
Counsel on conformance issues for SDTM or potentially ADaM and work with the review group to determine the issue either by amending the information or metadata, or by giving a fitting clarification.
Different obligations include:
Addressing AbbVie’s inclinations in industry norms improvement projects.
Remaining current with industry norms like CDISC, and the administrative necessities connected with their utilization.
Distinguishing upgrades to the cycles and content of norms and driving those enhancements to the end.
May oversee 3 or more straightforward reports.
This job can be based remotely anyplace inside the U.S.
