Electronic Data Capture (EDC) systems (e.g., Medidata, Medrio, or similar). Develop and oversee maintenance all data management... managing data across multiple phases of clinical trials Proficiency with EDC systems (e.g., Medidata Rave, Medrio...
Responsibilities: Maintain and update EDC user access across multiple clinical studies Track and manage user... access requests in coordination with CRAs and EDC vendors Curate and maintain standardized tracking spreadsheets...
. Perform risk-based audits of specific clinical processes. Conduct clinical vendor audits with SMEs (e.g., IRT, EDC). Develop...
and technical solutions such as eTMF, IWRS, EDC, etc. and developing presentation material. Successfully develops strategic...
research certification (e.g., ACRP or SOCRA). Experience with electronic data capture (EDC) systems and clinical trial...
in a related field or clinical research certification (e.g., ACRP or SOCRA). Experience with electronic data capture (EDC) systems...
goals Preparing appropriate paperwork for Individual Annual Review, IEP/EDC meetings Revising plans on an ongoing basis...
for PV automation and technology (i.e. e2B, eDC, AI, safety mailings) to proactively motivate change to maintain compliance...
) and site files to ensure completeness and accuracy. Provide site training and support for EDC and trial systems Contribute...
, and validation of clinical databases using Medidata Rave EDC, ensuring optimal configuration and functionality. Conduct thorough... of oncology-specific data requirements and challenges. Expert-level proficiency with Medidata Rave EDC, including system...