Data Acquisition Expert - EDC (Homebased UK/South Africa)

IQVIA; Centurion; On-site; ZAR 900,000 - 1,300,000; Full time

Job summary

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence. The EDC Data Acquisition Expert role focuses on defining and implementing EDC tools in alignment with trial protocols, collaborating with Data Managers, SRPs, SRSs and Biostatisticians.

You will design eCRF layouts, configure custom functions, and oversee EDC integration efforts, including IWRS and Rave migrations.

Qualifications

• Minimum of 5 years' experience building EDC databases in support of clinical research.
• Technical EDC build experience in Medidata Rave implementing complex database builds.
• Demonstrated project management skills.
• Advanced Custom functions programming knowledge.
• Experience working on clinical trials.
• Experience working in highly diverse teams within clinical research; cross-functional, global, multiregional.
• Working knowledge of GCP/ICH guidelines.
• Knowledge of CDASH.

Responsibilities

• Assess EDC collection requirements per protocol and create study start-up eCRF package based on global eCRF libraries.
• Design eCRF layout including form dynamics.
• Program Edit check and Custom Function.
• Create and configure tSDV technical specifications, Safety Gateway integration specifications and Datamart mapping specifications.
• Implement EDC coding configuration based on trial defined coding requirements.
• Perform test and Prod Rave EDC Migration.
• Oversee planning, requirements, and implementation of IWRS integrations to EDC.
• Serve as subject matter expertise for complex elements of EDC database builds (including integrations).
• Serve subject matter expertise for complex elements of EDC database builds (including optimal custom functions implementation).
• Provide training to junior staff on EDC build and migration process and Tools.
• Participate in process, system, and tool improvement initiatives within clinical data management.

Skills

EDC database design

Clinical data management

Project management

Advanced custom function programming

GCP/ICH knowledge

CDASH

Cross-functional collaboration

Global multiregional teams

Tools

Medidata Rave

Rave integration

Job description

Reading, Berkshire, United Kingdom, Centurion, South Africa, Bloemfontein, South Africa, Livingston, West Lothian, United Kingdom, Bellville, South Africa, London, United Kingdom.

Full time

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The EDC Data Acquisition Expert performs activities relating to the definition and implementation of Clinical Electronic Data Capture tools (EDC) and related documents and processes aligned with Clinical Trial Protocol defined requirements for data capture.

Activities are performed in close collaboration with Data Managers, Study Responsible Physicians (SRP), Study Responsible Scientists (SRS), and Biostatisticians.

Responsibilities:

• Assess EDC collection requirements per protocol and create study start-up eCRF package based on global eCRF libraries.
• Design eCRF layout including form dynamics.
• Program Edit check and Custom Function.
• Create and configure tSDV technical specifications, Safety Gateway integration specifications and Datamart mapping specifications.
• Implement EDC coding configuration based on trial defined coding requirements.
• Perform test and Prod Rave EDC Migration.
• Oversee planning, requirements, and implementation of IWRS integrations to EDC.
• Serve as subject matter expertise for complex elements of EDC database builds (including integrations).
• Serve subject matter expertise for complex elements of EDC database builds (including optimal custom functions implementation).
• Provide training to junior staff on EDC build and migration process and Tools.
• Participate in process, system, and tool improvement initiatives within clinical data management.

This role is not eligible for UK visa sponsorship.

Requirements:

• Minimum of 5 years' experience building EDC databases in support of clinical research.
• Technical EDC build experience in Medidata Rave implementing complex database builds.
• Demonstrated project management skills.
• Advanced Custom functions programming knowledge.
• Experience working on clinical trials.
• Experience working in highly diverse teams within clinical research; cross-functional, global, multiregional.
• Working knowledge of GCP/ICH guidelines.
• Knowledge of CDASH.

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 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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