Clinical Data Specialist - Hybrid - Bloemfontein

Perform comprehensive data management tasks including data review, query generation and query resolution. This may also include, but is not limited to creation of eCRF completion guidelines, entry of test data for eCRF and the Data Review Model, testing of data validation rules, etc. Data Management tasks should be inclusive of Study Start-up, Execution, Database Lock and Close-out.

Responsibilities:

• Perform ongoing Data Reconciliation of all data streams
• Attend study related meetings/teleconferences
• Perform Study Closeout/Archiving Activities including QC of subject/site archival CRFs
• Create and provide status/metric reports
• Generate reports on EDC and track cleaning progress
• Manage Freeze / lock of eCRF
• File documentation in the virtual Trial Master File (TMF)
• Receives and enters lab normal ranges

Advanced Responsibilities:

• Provide timely status updates including issues & risks to GDM and DMLs as needed
• Act as the Point of contact for Global Data Manager/Clinical Data Manager, working pro-actively to identify risks and provide mitigations
• May communicate with the vendors to resolve reconciliation issues.
• Provide input to Study set up activities including but not limited to creation of DVRs
• Create and/or provide inputs to Data Management documents (e.g. eCRF completion guidelines, etc.).
• Review and provide inputs to Data Management documents (e.g. IRP, DMP, etc.)
• Assign work to allocated CDAs on a trial. Coordinate work of CDAs assigned to a study working closely with the Global Data Manager to understand priorities and timelines.
• Assist the Data Management Leader in TMF compliance reviews.
• Train and mentor CDA staff

Education and Experience Guidelines:

• Bachelor’s degree in a Health or Science discipline with experience in clinical research.
• Data Management experience and experience working on a clinical trial mandatory.
• Experience working in highly diverse teams within clinical research; cross-functional, global, multi-regional.
• Knowledge of current industry standards (e.g., CDISC, SDTM, CDASH, etc.) for Advanced CDA.
• Knowledge of technology platforms and systems to capture and process data
• Project management skills.
• Vendor management skills.
• Proficiency with Microsoft Office tool
• Highly organized with excellent written and verbal communication.
• Ability to interpret clinical trial data and present trends to clinical trial team on data.

Experience CDA BASE level: 1-3 years of experience.

Experience CDA ADVANCED level: >3 year of experience

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