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

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

Job summary

IQVIA in Bloemfontein seeks an EDC Data Acquisition Expert to define and implement electronic data capture tools for clinical trials, collaborating with Data Managers, SRP, SRS and Biostatisticians. You will design eCRF layouts, program edit checks and functions, configure technical specs, and support IWRS integrations.

The role focuses on complex EDC builds and CDASH/GCP adherence. Applicants should have 5+ years of EDC database experience, Medidata Rave expertise, proven PM skills, and

Qualifications

• 5+ years’ experience building EDC databases in 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 diverse, global, multiregional teams.
• 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 checks and Custom Functions.
• 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 development

Medidata Rave

Project management

Advanced custom functions

Clinical trials experience

Cross-functional collaboration

CDASH knowledge

GCP/ICH knowledge

Tools

Medidata Rave

IWRS integrations

Job description

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

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

This role is not eligible for UK visa sponsorship

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.