Senior Data Coordinator
Job Title: Senior Data Coordinator
Report to: Head of Data Management
- Serves as clinical data coordinator for one or more projects
- Supports and works closely with study lead data manager(s) for assigned clinical studies.
- Review clinical trial data based on protocol, edit specifications to identify erroneous, missing, incomplete, or implausible data
- Assist with the aggregate review of clinical data by patient, site and/or project to identify data trends(compliance, etc.) and/or data in consistencies that require further investigation
- Generate, resolve and track queries to address problematic data identified during data review activities
- Contribute to DM part of EDC UAT for clinical database build and modifications
- Ensures laboratory data, if applicable, and associated lab normal ranges are reviewed and reconciled
- Assist with the reconciliation of central laboratory and/or third party vendor data, in addition to serious adverse event reconciliation
- Participates in UAT activities for data transfers and programmed listings/report
- Prepare data listings or data extracts for medial reviews and progress report specifically
- Generates and delivers reports to study team members
- Assists with Site and User management in clinical database of assigned clinical studies.
- Maintain data management study documentation as appropriate
- Perform other duties as assigned by management
- Produce assigned work within the timelines provided ensuring deadlines are met.
- Bachelor degree or equivalent
- 2+ year’s working experience in data management in pharmaceutical industry, experience in oncology studies is preferred.
- Understand clinical data management systems or electronic data capture software
- Functional expertise (including understanding of data management process, industry guideline, etc)
- Good understanding of regulations and guidelines (e.g. ICH, GCP)
- Strong written and oral communication skills in local language and English – Ability to work in a matrix organization