Senior EDC Developer

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Develop and maintain a library of eCRF templates that comply with CDASH standards, along with supplementary documentation.

• Offer technical oversight, support, training, and guidance to both Sponsors and the Ergomed clinical and business development teams.

• Assist in validation activities and the necessary documentation for systems.

• Create and evaluate EDC systems concerning their structure, workflow, edit checks, as well as user roles and permissions.

• Ensure the involvement of stakeholders and compliance with EDC creation timelines.

• Utilize SAS, SQL, Python, and Power BI to generate data listings, reports, quality checks, dashboards, and metrics.

• Supervise documentation related to study-level EDC systems.

• Provide ongoing technical oversight, training, support, and guidance throughout the study lifecycle.

• Conduct gap analyses for EDC systems not developed by Ergomed.

• Manage data migrations and coordinate with external vendors concerning transferred or imported data.

• Administer coding dictionaries, including updates and licensing for WHO Drug and MedDRA versions.

• Oversee bi-annual upgrades of coding dictionaries.

• Manage and implement changes to EDC systems post-launch.

• Handle site and user account management, including record maintenance and periodic reviews.

⛳️ Requirements

• Essential experience with Medidata RAVE and Zelta v1.0.

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

• Advanced expertise in data systems.

• Accreditation in at least one clinical trial EDC system, such as Zelta or Medidata Rave.

• Experience in the creation of EDC systems and programming edit checks.

• Proficiency in data standards (CDASH and SDTM) and their application in EDC system development.

• CDASH Certification is preferred.

• Strong communication skills.

• A collaborative and team-oriented mindset.

• Self-motivated with the capacity to work independently.

🏝️ Benefits

• Option for remote work.

• A collaborative and passionate team atmosphere.

• Training, support, and guidance throughout the study lifecycle.

• Opportunity to positively impact patients' lives.

• A diverse and inclusive work environment.

• Opportunities for growth and professional development.