EDC Developer (Medidata RAVE and Zelta v1.0)

About the role

Ergomed Group, which brings together Ergomed CRO, PrimeVigilance, Prudentia and ADAMAS Consulting, supports biopharmaceutical companies in developing, delivering and safeguarding therapies in oncology, rare diseases and other complex areas. The EDC Developer in the Data Management department builds EDC applications for complex projects, reporting to the Director of Data Management and to the Project Data Manager on a project basis.

Key responsibilities

• Create the EDC system structure, workflow, edit checks and user roles and permissions, based on data standards (CDASH), study protocol and standard eCRF templates
• Include randomisation, ePRO (licensing, validation and translation), IMP management and targeted SDV where applicable, plus other non-core EDC functionality
• Produce study-level EDC documentation such as specifications, test plans and study-specific training materials
• Perform post-live changes to the EDC system and reporting applications under the Change Control process

Required profile

• Graduate or bachelor's degree in Life Sciences, Pharma or a related health discipline from an accredited institution
• Prior experience creating EDC systems and writing edit checks is a must
• Effective communication, cooperative and self-motivated, able to work independently

Required skills

• Medidata RAVE and Zelta v1.0 experience is essential
• Proficiency in CDASH and SDTM standards, with CDASH certification preferred