The clinical documentation improvement department is part of clinical informatics. This department provides the opportunity to learn new skills, new software, and work closely with physicians, informaticists and coders.
Evaluate and review data and study analytical reports and assay validation reports, as appropriate, to ensure laboratories are performing analysis in compliance with current regulatory, industry, and Pfizer standards and that data are meeting regulatory and scientific requirements.
In this role, you will facilitate the development of nursing and the advancement of professionalism in clinical practice by acting as a role model in clinical practice through the use of consultation, education and research.
Manage projects as they relate to Pfizers Clinical Data Management Systems (CDMS). Analyze multiple models/systems to ensure data integrity and documented, defensible collection/management of these data. Partner with global Clinical Trial Process Quality (CTPQ) regarding process across models.
In this role, the selected candidate will analyze medical records received from enrolling sites to identify AEs (Adverse Events), SAEs (Serious Adverse Events) or UADEs (Unanticipated Adverse Device Effects) to confirm protocol definition and propose recommendations to site.
Will assist the Clinical Project Manager and/or Clinical Affairs representative as a team leader on assigned project teams to provide clinical guidance, strategy, and support for the development of new technologies, new products, and extended product claims.