Senior Clinical Data Associate — Lead Data Management

IQVIA; Cape Town; Vor Ort; ZAR 600.000 - 900.000; Vollzeit

Zusammenfassung

IQVIA is hiring for a Data Management CDA Advanced role in South Africa (Cape Town area). You will operate as the data management lead on trials, act as liaison to the Clinical Data Manager, and coordinate with CDAs and vendors to ensure data integrity and timely deliverables.

Responsibilities include creating input to DVRs, eCRF guidelines, data management documents, and TMF compliance reviews, while mentoring CDA staff and participating in SME forums.

Qualifikationen

• Bachelor’s degree in a Health or Science discipline with experience in clinical research.
• Experience CDA Advanced level: >3 year of experience Data Management experience
• 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/process data
• Project management skills
• Vendor management skills
• Proficiency with Microsoft Office tools

Aufgaben

• Provide timely status updates including issues & risks to DM and DMLs as needed
• Act as the Point of contact for Clinical Data Manager
• May communicate with vendors to resolve reconciliation issues
• Provide input to Study set up activities including DVR creation
• Create and/or provide inputs to Data Management documents (e.g. eCRF completion guidelines)
• Review and provide inputs to Data Management documents (e.g. IRP, DMP)
• Assign work to allocated CDAs on a trial and coordinate with Global Data Manager
• Assist the Data Management Leader in TMF compliance reviews
• Train and mentor CDA staff
• May serve as SME and participate in SME forums
• May act as delegate for Data Manager as needed

Kenntnisse

CDA Advanced

CDISC knowledge

SDTM knowledge

CDASH knowledge

Project management

Vendor management

MS Office

Data management experience

Clinical trial experience

Ausbildung

Bachelor’s degree in Health or Science

Tools

Rave

Microsoft Office

Jobbeschreibung

IQVIA is hiring for a Data Management CDA Advanced role in South Africa (Cape Town area). You will operate as the data management lead on trials, act as liaison to the Clinical Data Manager, and coordinate with CDAs and vendors to ensure data integrity and timely deliverables.

Responsibilities include creating input to DVRs, eCRF guidelines, data management documents, and TMF compliance reviews, while mentoring CDA staff and participating in SME forums.