EDC Developer – Full-time, 6 month contract

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

📋 Description

• Develop EDC systems, encompassing their 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.

• Integrate relevant additional EDC functionalities, such as randomisation, ePRO, IMP Management, and Targeted SDV.

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

• Generate study-level EDC system documentation, including specifications, test plans, and tailored training materials for 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 oversight from the Project Data Manager.

⛳️ Requirements

• Experience with Zelta v2.0 is a must.

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

• Prior experience in EDC system development and Edit Check programming is essential.

• Strong communication skills are necessary.

• A collaborative and team-oriented mindset is required.

• Self-motivation and the ability to work independently are crucial.

• Proficiency in data standards CDASH and SDTM, along with their application in EDC system development, is needed.

• CDASH Certification is preferred.

🏝️ Benefits

• A dedicated and collaborative team of professionals in clinical research, pharmacovigilance, and quality consulting.

• A diverse and inclusive work environment where every voice is valued.

• Option for remote work.

• An opportunity to significantly impact patients' lives.

• Opportunities for professional growth.