Configuration Subject Matter Expert (SME) – Medidata Platform

Configuration Subject Matter Expert (SME) – Medidata Platform

Rate: 1000-1300 PLN/day

Are you an expert in clinical trial systems configuration? We’re looking for a Configuration Subject Matter Expert (SME) to join our team and lead the configuration of Medidata’s Clinical Trial Management Systems (CTMS), Site Start-Up (SSU), Electronic Data Capture (EDC), Site Payments, and electronic Trial Master File (eTMF).

This is a key role responsible for managing core system configurations, supporting data migration, and integrating platforms to streamline processes across our clinical operations.

Responsibilities:

• Collaborate with Medidata to manage and maintain core configurations for CTMS/SSU, EDC, eTMF, and Site Payments systems, aligning with business needs.

• Create and review essential documentation, including Functional Requirement Specifications (FRS), Configuration Specifications (CS), Technical Specifications, and Installation Qualification (IQ) documents.

• Coordinate with external vendors to ensure accurate and timely technical deliverables.

• Support migration mapping and data configuration to ensure integrity and regulatory compliance during system transitions.

• Facilitate system integrations to optimize functionality across clinical platforms.

Requirements:

• Experience: 5+ years in system configuration or administration, specifically in CTMS/SSU, EDC, eTMF, or Site Payments.

• Technical Expertise: Hands-on experience with Medidata systems and strong familiarity with configuration documentation standards.

• Domain Knowledge: Solid understanding of clinical trial processes and regulatory frameworks.

• Interpersonal Skills: Strong communication and collaboration abilities, capable of working effectively with cross-functional teams and external partners.