Clinical Data Associate - Base

IQVIA; Cape Town; On-site; ZAR 1,308,000 - 1,769,000; Full time

Job summary

IQVIA in Cape Town, Western Cape, South Africa, is hiring for a base level Data Management role to support clinical data throughout study start-up, execution, database lock and close-out. You will perform data review, query generation, resolution, data reconciliation and TMF filing.

The ideal candidate has a BA/BS in health or science field, 1–3 years in clinical data management, and Rave plus MS Office proficiency.

Qualifications

• Bachelor’s degree in a health or science discipline with clinical research experience.
• Data management experience and working on a clinical trial is mandatory.
• Rave experience is mandatory.
• Experience collaborating with diverse, cross-functional, global teams.
• Knowledge of CDISC/SDTM/CDASH guidelines for advanced CDA.
• Proficiency with Microsoft Office tools and data capture platforms.

Responsibilities

• Perform data management tasks including data review, query generation and resolution.
• Attend study start-up, execution, database lock and close-out data activities.
• Conduct ongoing data reconciliation of data streams.
• Attend study meetings and teleconferences.
• Manage eCRF freeze/lock and TMF documentation.
• Generate status/metrics reports and report on EDC progress.

Skills

Data management

Rave experience

Cross-functional collaboration

Project management

Vendor management

Education

Bachelor’s degree in Health/Science

Tools

Rave

Microsoft Office

Job description

Bloemfontein, South Africa

Cape Town, Western Cape, South Africa

Centurion, South Africa

Full time

R1538302

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

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 in Data Management at a CRO/Pharma

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

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.

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