Clinical Data Associate

IQVIA; Cape Town; On-site; ZAR 250,000 - 450,000; Full time

Job summary

A leading global provider of clinical research services is seeking a Clinical Associate in Cape Town. The role involves managing data for clinical trials, participating in meetings, and mentoring staff. Candidates should possess a relevant degree and experience within clinical research, particularly with systems like Rave.

Benefits

Opportunity for professional development

Work in an internationally diverse team

Qualifications

• Bachelor’s degree in a relevant field and experience in clinical trials.
• Mandatory data management experience with Rave.
• 1-3 years' experience for BASE level; >3 years for ADVANCED.

Responsibilities

• Perform comprehensive data management tasks including data review and query resolution.
• Attend study-related meetings and provide status reports.
• Train and mentor CDA staff.

Skills

Clinical research experience

Data Management

Team collaboration

MS Office proficiency

Knowledge of industry standards (e.g., CDISC)

Education

Bachelor’s degree in a Health or Science discipline

Tools

Rave

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).

Receive and enter lab normal ranges.

Provide timely status updates including issues & risks to DM and DMLs as needed.

Act as the Point of contact for Clinical Data Manager, working proactively to identify risks and provide mitigations.

May communicate with vendors to resolve reconciliation issues.

Provide input to Study setup activities including but not limited to creation of DVRs.

Create and/or provide inputs to Data Management documents (e.g., eCRF completion guidelines, IRP, DMP).

Review and provide inputs to Data Management documents.

Assign work to CDA staff on a trial, coordinating 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.
• 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

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Clinical Associate • Cape Town, Western Cape, South Africa