Senior Clinical Data Associate

IQVIA; Centurion; On-site; ZAR 700,000 - 1,100,000; Full time

Job summary

IQVIA is seeking a Senior CDA to lead data management activities on global clinical trials from our Centurion office. You will coordinate CDA work, mentor staff and collaborate with the Global Data Management team to ensure TMF compliance and timely study deliverables.

The role requires a Bachelor’s degree in health or science, more than three years of CDA/Data Management experience, Rave expertise, and strong knowledge of CDISC SDTM/CDASH.

Qualifications

• Bachelor’s degree in health or science with clinical research experience.
• Advanced CDA: 3+ years of data management experience.
• Data management on a clinical trial is mandatory.
• Rave experience mandatory.
• Experience in diverse, cross-functional, global teams.
• Knowledge of CDISC SDTM/CDASH for Advanced CDA.
• Knowledge of platforms to capture and process data.
• Strong project and vendor management skills.
• Proficiency with Microsoft Office tools.

Responsibilities

• Provide timely status updates including issues & risks to DM and DMLs as needed
• Act as the Point of contact for Clinical Data Manager, pro-active to identify risks and mitigations
• May communicate with vendors to resolve reconciliation issues
• Provide input to Study set up activities including DVR creation
• Create and/or provide inputs to Data Management documents (eCRF completion guidelines, etc.)
• Review and provide inputs to Data Management documents (IRP, DMP, etc.)
• Assign work to allocated CDAs on a trial; coordinate with Global DM on priorities
• Assist the Data Management Leader in TMF compliance reviews
• Train and mentor CDA staff; may serve as SME

Skills

CDA advanced level

Rave experience

CDISC standards

SDTM/CDASH knowledge

Project management

Vendor management

MS Office proficiency

Education

Bachelor’s degree in Health or Science

Tools

Rave

Job description

Bloemfontein, South Africa

Cape Town, Western Cape, South Africa

Centurion, South Africa

Full time

• 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

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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