Contribute to developing eCRFs, CRF Completion Guidelines, Edit check specs, and DMP.
Contribute to study tracking and metric reports for use by the study team Contribute to CRF tracking and data entry, integration of external electronic data, data validation and review, query processing and resolution, adverse event and medication coding, SAE reconciliation, database lock and database QC audits.
Contribute to user acceptance testing (UAT) of EDC and integrated systems including executing of test plan and scripts.
Assist with preparation for training sites/users training on EDC applications, and UAT.
End user knowledge for study conduct activities including queries management, standard reporting and extracting data.
Learning to develop data entry screens, dynamics, edit checks and other EDC components.
Requirements
Bachelors Degree in a scientific, medical, or clinical discipline or related field is required; Master s or PhD preferred
2-5 years of previous experience in clinical data management
Hands-on experience with clinical trials and pharmaceutical development preferred
Effective problem-solving and data analysis skills
Experience in the pharmaceutical or CRO industry must
Experience with query and discrepancy management required