Senior Clinical Data Associate

IQVIA LLC; Bloemfontein; On-site; ZAR 600,000 - 900,000; Full time

Job summary

IQVIA is seeking an Advanced CDA to provide timely status updates to the Data Manager and DMLs, act as the main contact for the Clinical Data Manager, and coordinate CDAs on trials with global teams.

You will proactively identify risks and mitigations and support TMF compliance reviews.Education and experience: Bachelor’s degree in Health or Science, >3 years in Data Management on clinical trials, RAVE experience, knowledge of CDISC, SDTM, and CDASH, plus strong vendor and project management

Qualifications

• Bachelor’s degree in a Health or Science discipline, with experience in clinical research.
• Advanced CDA with >3 years Data Management experience and Rave experience mandatory.
• Experience on a clinical trial in diverse, cross-functional, global teams; knowledge of CDISC, SDTM, CDASH.

Responsibilities

• Provide timely status updates to the Data Manager (DM) and DMLs; act as the main contact for the Clinical Data Manager; coordinate work of CDAs on trials with global teams; identify risks and mitigations; assist TMF compliance reviews.
• Contribute to study setup activities and data management documents (e.g., DMP, IRP); review inputs to ensure alignment with CDISC standards.

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

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.