Clinical Data Associate - Hybrid (Bloemfontein)

IQVIA Argentina; Bloemfontein; On-site; ZAR 300,000 - 600,000; Full time

Job summary

An established industry player is seeking a dedicated Data Manager to join their dynamic team. This role involves performing comprehensive data management tasks, ensuring data integrity throughout the clinical trial process, and collaborating with diverse teams to drive project success. You will be responsible for data reconciliation, documentation management, and providing timely updates to stakeholders. With a focus on quality and compliance, this position offers an exciting opportunity to contribute to innovative medical treatments that improve patient outcomes. If you are passionate about clinical research and thrive in a collaborative environment, this role is perfect for you.

Qualifications

• Bachelor's degree in a relevant discipline with clinical research experience.
• 1-3 years experience for base level, >3 years for advanced level.

Responsibilities

• Perform data management tasks including data review and query resolution.
• Act as point of contact for Clinical Data Manager and manage team coordination.
• Create and provide status reports and manage documentation in TMF.

Skills

Data Management

Clinical Research

Project Management

Vendor Management

Communication

Education

Bachelor’s degree in Health or Science

Tools

Microsoft Office

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.
• 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 years 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