Vacancy caducado!
Associate I, Clinical DocumentationUSA, Illinois, Lake CountyNewResearch & DevelopmentRequisition #2002101Master File Owner” responsible for managing and ensuring inspection readiness of clinical documentation /master files. CDC representative on study team(s) with ownership of the study Trial Master File (TMF).Responsibilities :
Ensures real-time inspection readiness of clinical documentation / TMF by performing quality control (QC)of the TMF/artifacts to ensure completeness, document quality and timeliness of upload of artifacts to theTMF.
Collaborates with Artifact owners, holds study team members accountable for respective sections of theTMF, reports status to study team members by providing regular status updates & facilitating/leading routine TMF "health" meetings and documents the discussion/decisions made in the TMF.
Develops and maintains study-specific TMF structure documentation (i.e. Expected Document List, exceltrackers for paper/hybrid TMF).
Provides support and prepares TMF(s) for audits / inspections.
Contributes to functional area continuous improvement projects and/or work streams.
Complies with GCP, AbbVie SOPs and functional area processes.
Bachelor degree or international equivalent is required.
At least 2 years of professional working experience.
Demonstrates analytical and critical thinking skills.
Good oral and written communication skills; ability to facilitate cross-functional team meetings.
Ability to manage a few projects at the same time.
Demonstrates awareness of clinical documentation business procedures.
Experience working in documentation systems.
Additional Information
Significant Work Activities and Conditions: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel: No
Job Type: Experienced
Schedule: Full-time
Job Level Code: IC
Vacancy caducado!