Clinical Data Associate - Base

IQVIA; Bloemfontein; On-site; ZAR 360,000 - 540,000; Full time

Job summary

IQVIA is a leading global provider of clinical research services, with a focus on data management for clinical trials. The role involves comprehensive data management tasks across study start-up, execution and close-out, including data review, reconciliation and query resolution, in a global, cross-functional setting.

We seek candidates with a health/science degree, 1–3 years of data management experience at CRO/Pharma, and mandatory Rave experience.

Qualifications

• Bachelor's degree in Health or Science with experience in clinical research.
• Data Management experience and experience working on a clinical trial mandatory.
• Rave experience mandatory.
• Experience working in diverse, cross-functional, global teams.
• Knowledge of industry standards (CDISC, SDTM, CDASH) for Advanced CDA.
• Knowledge of platforms and systems to capture and process data.
• Project management skills.
• Vendor management skills.
• Proficiency with Microsoft Office tools.
• Experience CDA BASE level: 1–3 years in Data Management at a CRO/Pharma.

Responsibilities

• Perform comprehensive data management tasks including data review, query generation and query resolution.
• Data Management tasks should include Study Start-up, Execution, Database Lock and Close-out.
• 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.

Skills

Data management

Query resolution

Data review

Cross-functional teamwork

Project management

Vendor management

MS Office

Education

Bachelor's degree in Health or Science

Tools

Rave

Microsoft Office

Job description

• 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.
• 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

Base level role

• 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.
• 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

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.
• Rave experience 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 tools
• Experience CDA BASE level: 1-3 years of experience in Data Management at a CRO/Pharma

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.