Clinical Data Specialist - Hybrid - Bloemfontein

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

Job summary

An established industry player is seeking a detail-oriented Data Manager to oversee comprehensive data management tasks within clinical trials. This role involves performing data reconciliation, managing eCRF processes, and ensuring compliance with industry standards. The ideal candidate will have a Bachelor's degree in a relevant field and experience in clinical research, along with strong project and vendor management skills. Join a global leader in clinical research services and contribute to improving patient outcomes through innovative medical treatments. If you thrive in a collaborative environment and are passionate about data integrity, this position is perfect for you.

Qualifications

• Bachelor's degree in Health or Science required with experience in clinical research.
• 1-3 years of Data Management experience mandatory.

Responsibilities

• Perform ongoing Data Reconciliation of all data streams.
• Create and provide status/metric reports on data cleaning progress.
• Train and mentor CDA staff for effective project execution.

Skills

Data Management

Clinical Research

Project Management

Vendor Management

Communication Skills

Organizational Skills

Education

Bachelor’s degree in Health or Science

Tools

Microsoft Office

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.

Responsibilities:

• 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

Advanced Responsibilities:

• Provide timely status updates including issues & risks to GDM and DMLs as needed
• Act as the Point of contact for Global Data Manager/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

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 tool
• Highly organized with excellent written and verbal communication.
• Ability to interpret clinical trial data and present trends to clinical trial team on data.

Experience CDA BASE level: 1-3 years of experience.

Experience CDA ADVANCED level: >3 year 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 IQVIA Careers