Must have

• CTMS/SSU

• EDC

• eTMF

• Medidata systems

• English

Requirements description

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.

Offer description

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.

Your responsibilities

1. Collaborate with Medidata to manage and maintain core configurations for CTMS/SSU, EDC, eTMF, and Site Payments systems, aligning with business needs.
2. Create and review essential documentation, including Functional Requirement Specifications (FRS), Configuration Specifications (CS), Technical Specifications, and Installation Qualification (IQ) documents.
3. Coordinate with external vendors to ensure accurate and timely technical deliverables.
4. Support migration mapping and data configuration to ensure integrity and regulatory compliance during system transitions.
5. Facilitate system integrations to optimize functionality across clinical platforms.