EDC Developer, Zelta v2.0 Certified

This is a fully remote position, open to applicants in Serbia, +1 more country.

📋 Description

• Develop EDC systems that encompass structure, workflow, edit checks, as well as user roles and permissions.

• Construct EDC systems in accordance with CDASH data standards, study protocols, and established eCRF templates.

• Implement additional functionalities within EDC systems when necessary, such as randomization, ePRO, IMP Management, and Targeted SDV.

• Manage ePRO licensing, validation, and translation as needed.

• Generate study-level EDC documentation, which includes specifications, test plans, and training materials specific to the study.

• Execute post-live modifications to EDC systems and relevant reporting applications following the Change Control process.

• Operate under the guidance of the Director of Data Management with project-level supervision from the Project Data Manager.

⛳️ Requirements

• Experience with Zelta v2.0 is crucial.

• A graduate or bachelor's degree in Life Sciences, Pharmacy, or a related health discipline from an accredited institution is required.

• Previous experience in the creation of EDC systems and programming Edit Checks is necessary.

• Strong communication skills are essential.

• A collaborative and team-oriented mindset is important.

• Self-motivation and the ability to work autonomously are required.

• Familiarity with data standards CDASH and SDTM, and their application in EDC system development is expected.

• CDASH Certification is preferred.

🏝️ Benefits

• Full-time, 6-month contract opportunity.

• Flexibility to work remotely.

• Professional exposure within Ergomed Group’s teams specializing in clinical research, pharmacovigilance, and quality consulting.

• A collaborative, diverse, and inclusive work atmosphere.

• Opportunities for growth and development.

• Chance to make a significant impact on patients’ lives.