Clinical Data Associate - Advance

IQVIA; Bloemfontein; On-site; ZAR 600 000 - 800 000; Full time

Job summary

A leading global clinical research provider is seeking a Clinical Data Manager in Bloemfontein, South Africa. This advanced level role involves providing timely status updates, acting as a point of contact for the Clinical Data Manager, and leading a team of CDAs. The ideal candidate will have over 3 years of data management experience, Rave expertise, and a Bachelor’s degree in a relevant field. Join us and contribute to improving patient outcomes across the globe.

Qualifications

• 3+ years of Data Management experience in clinical trials.
• Proven experience in project and vendor management.
• Knowledge of industry standards like CDISC, SDTM, and CDASH.

Responsibilities

• Provide timely status updates to management.
• Act as the main contact for Clinical Data Manager.
• Assign and coordinate work for allocated CDAs on a trial.
• Train and mentor CDA staff.

Skills

Communication with vendors

Risk identification

Clinical data management

Team collaboration

Project management

Microsoft Office proficiency

Education

Bachelor’s degree in Health or Science discipline

Tools

Rave

Job description

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.

• 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 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

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