Clinical Data Associate - Hybrid (Bloemfontein)

IQVIA; Centurion; On-site; ZAR 300 000 - 600 000; Full time

Job summary

An established industry player is seeking a dedicated Clinical Data Associate to join their dynamic team. This role involves comprehensive data management tasks, ensuring the accuracy and integrity of clinical trial data. You will be responsible for performing data reconciliation, generating reports, and collaborating with diverse teams to drive clinical research forward. With a focus on innovation and patient outcomes, this position offers a unique opportunity to contribute to the development of groundbreaking medical treatments. If you are passionate about clinical research and thrive in a collaborative environment, this role is perfect for you.

Qualifications

• Bachelor’s degree in Health or Science with clinical research experience.
• Data Management experience and Rave experience are mandatory.

Responsibilities

• Perform comprehensive data management tasks including data review and query resolution.
• Provide timely status updates and act as the point of contact for Clinical Data Manager.

Skills

Data Management

Clinical Research

Rave

Project Management

Vendor Management

Microsoft Office

Team Collaboration

Education

Bachelor’s degree in Health or Science

Tools

EDC

Trial Master File (TMF)

Job description

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.

Advance level role

• Provide timely status updates including issues & risks to DM and DMLs as needed.
• Act as the Point of contact for 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.
• May serve as an SME and participate in SME forums.
• May act as delegate for Data Manager, as needed.

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.
• Experience CDA ADVANCED level: >3 year of experience.

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.