Associate Clinical Data Analyst
Parexel International Corporation
Shenyang Wobu, Liaoning, China
The Clinical Data Analyst II (CDA II) shall perform all clinical data cleaning activities on assigned projects, commensurate with experience and/or project role. Further responsibilities shall include support on data processing activities and study level documents e.g. Protocol Deviation Specification, Data Validation specification, etc.
Lead/Responsible for data cleaning and data review
activities e.g. query management.
Review of protocols and EDC Screens if required.
Support data processing activities from database
setup to database lock, e.g. SAE reconciliation.
Perform user acceptance testing on study database
Perform medical coding on small studies
Track and review CRFs. Support data entry where
Perform and or support the setup of DM documents
and ensure proper documentation e.g. CRF
Completion Guidelines (CCG)
Perform/lead functional QC activities and testing
Mentor project team members
Be a subject matter expert when neededQualificationsGood interpersonal, verbal and written communication skills
Knowledge of medical terminology and awareness of coding dictionaries (e.g.MedDRA &
Ability to work in team environment
Good analytical skills and attention to detail
Effective time management to meet daily metrics or team objectives, completion of assigned
tasks in a timely manner
Robust knowledge of ICH-GCP Guidelines, local regulatory requirements and PAREXEL SOPs
and study specific procedures
Good knowledge of EDC systems (e.g. DataLabs, Rave.)
Good knowledge of electronic source data capture systems (e.g. ClinBase)
Good knowledge of all DB set- up activities including but not limited to Database Configuration
Specifications, Data Validation
Basic knowledge of SAS
Bachelor’s degree and / or other medical qualifications or relevant industry experience