The Senior Manager, Clinical Data and Reporting Standards (CDARS) proactively participates in the development of data and reporting standards in support of AbbVie’s portfolio of clinical trials, and ensuring AbbVie’s conformance to CDISC standards and industry best practices. This role implements the strategy and framework for governance of standards as set by the Head and Associate Directors of CDARS, and actively engages in deployment of next generation process and technology.
Responsibilities:
- Lead or participate in a cross-functional team of subject matter experts to define at least one of the following types of standards within the assigned therapeutic area: Data Collection, Data Review Rules, SDTM mapping, ADaM mapping and derivation, Study-level tables, listings, or figures, Product-level safety analysis displays
- Ensure each standard is clearly defined, with appropriate documentation of relevant assumptions and decisions related to its use to support pipeline activities
- Support educating the organization on the proper use of standards in pipeline activities by contributing to the development of training materials; communicate ongoing standard development activities across the organization
- Provide feedback on CRF design and SDTM datasets to ensure data are collected and represented in a manner that support regulatory requirements to comply with CDISC standards (CDASH, SDTM and ADaM) and AbbVie standard extensions to CDISC
- Review and provide feedback on SDTM Trial Design Domains
- Oversee the creation of SDTM define.xml, annotated CRF and Clinical Study Data Reviewer’s Guides for both FDA and PMDA submissions
- Consult on conformance issues for SDTM and/or ADaM and work with the study team to resolve the problem either by correcting the data or metadata, or by providing an appropriate explanation
- Other responsibilities include: representing AbbVie’s interests in industry standards development projects; staying current with industry standards such as CDISC, and the regulatory requirements related to their use; identifying improvements to the processes and content of standards, and driving those improvements to completion
- May manage 3 or more direct reports
