Clinical Data Associate - Hybrid (Bloemfontein)

IQVIA; Cape Town; On-site; ZAR 30 000 - 70 000; Full time

Job summary

An established industry player is seeking a dedicated Data Manager to oversee comprehensive data management tasks in clinical research. This role involves ensuring data integrity through meticulous review and reconciliation processes, while also providing critical updates and acting as a liaison with clinical teams and vendors. The ideal candidate will possess a strong background in data management, particularly with eCRF systems, and will thrive in a dynamic, cross-functional environment. Join a forward-thinking company that is committed to improving patient outcomes through innovative medical treatments.

Qualifications

• Bachelor’s degree in a Health or Science discipline with clinical research experience.
• Mandatory experience in Data Management and clinical trials.

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

Education

Bachelor’s degree in Health or Science

Tools

eCRF

Trial Master File (TMF)

Job description

Base level role

1. Perform comprehensive data management tasks including data review, query generation and resolution. This may include creating eCRF completion guidelines, entering test data for eCRF and the Data Review Model, testing data validation rules, etc. Data Management tasks should encompass Study Start-up, Execution, Database Lock, and Close-out.
2. Perform ongoing Data Reconciliation of all data streams.
3. Attend study-related meetings/teleconferences.
4. Perform Study Closeout/Archiving Activities, including QC of subject/site Archival CRFs.
5. Create and provide status/metric reports.
6. Generate reports on EDC and track cleaning progress.
7. Manage Freeze/lock of eCRF.
8. File documentation in the virtual Trial Master File (TMF).
9. Receive and enter lab normal ranges.

Advance level role

1. Provide timely status updates, including issues & risks, to DM and DMLs as needed.
2. Act as the Point of contact for Clinical Data Manager, proactively identifying risks and providing mitigations.
3. Communicate with vendors to resolve reconciliation issues.
4. Contribute to Study setup activities, including creating DVRs.
5. Create and/or provide inputs to Data Management documents (e.g., eCRF completion guidelines).
6. Review and provide inputs to Data Management documents (e.g., IRP, DMP).
7. Assign work to CDA staff on a trial and coordinate their work, working closely with the Global Data Manager to understand priorities and timelines.
8. Assist the Data Management Leader in TMF compliance reviews.
9. Train and mentor CDA staff.
10. May serve as an SME and participate in SME forums.
11. 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.
• Mandatory Data Management experience and experience working on a clinical trial.
• Rave experience is mandatory.
• Experience working in highly diverse, cross-functional, global, multi-regional teams.
• Knowledge of current industry standards (e.g., CDISC, SDTM, CDASH).
• Knowledge of technology platforms and systems for data capture and processing.
• Project management skills.
• Vendor management skills.
• Proficiency with Microsoft Office tools.
• Experience as CDA BASE level: 1-3 years.
• Experience as CDA ADVANCED level: >3 years.

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