Medidata SME Technical Lead

Who You Will Be Working For

Atlas is a global strategic consulting firm focused on the life sciences industry. Our services include Management Consulting, Managed Services, and Agile Services. Global pharmaceutical companies and emerging players in the life sciences industry depend on Atlas consultants to help drive innovation, operational excellence, and patient-first outcomes.

What You Will Do

We are seeking a Medidata Subject Matter Expert (SME) to serve as the Technical Lead across the Clinical Data platform ecosystem in support of a global life sciences client's Clinical Operations function. This role will be the go-to expert for the full Medidata suite — Rave/EDC, Coder, Clinical Data Studio, Rave Safety Gateway, Rave Companion, and Cloud Admin — providing end-to-end application support across L1.5, L2, and L3 tiers.

This individual will lead user access management, vendor coordination, validation support, and study configuration/setup activities, partnering across Clinical Data Management, Biostatistics, Clinical Operations, and Quality functions to ensure platform reliability, compliance, and continuous improvement.

Job Responsibilities

• Serve as the primary technical lead and SME for the Medidata application suite across L1.5, L2, and L3 support tiers

• Lead user access management activities, including provisioning, role assignment, periodic access reviews, and de-provisioning across all Medidata applications

• Coordinate with Medidata and other third-party vendors on incident resolution, service requests, change management, and platform releases

• Drive study setup activities including study build, configuration, and e-learning setup across Rave/EDC, Coder, Clinical Data Studio, Rave Safety Gateway, Rave Companion, and Cloud Admin

• Provide validation support as required, including authoring and executing test scripts, generating validation documentation, and maintaining audit-ready evidence

• Lead L3 activities for Medidata Rave/EDC including setup and core configuration updates for studies, clinical view refreshes, and PDF generation

• Lead L3 activities for Rave Safety Gateway, including study setup and ongoing maintenance

• Partner with Clinical Data Management, Biostatistics, and Clinical Operations stakeholders to translate study requirements into platform configurations

• Troubleshoot complex production issues, perform root cause analysis, and implement preventive measures

• Create and maintain SOPs, work instructions, configuration standards, and knowledge base articles for the Medidata platform

• Mentor L1.5 and L2 support analysts and serve as the escalation point for complex technical issues

Qualifications

• Bachelor's degree required; advanced degree preferred in Life Sciences, Computer Science, Information Systems, or a related field

• 7+ years of hands-on experience supporting and configuring Medidata Rave/EDC in a regulated clinical environment

• Deep working knowledge across the Medidata suite: Rave/EDC, Coder, Clinical Data Studio, Rave Safety Gateway, Rave Companion, and Cloud Admin

• Proven experience with study build activities — CRF design, edit checks, derivations, dynamics, and lab administration

• Strong understanding of clinical data standards (CDISC, CDASH, SDTM) and clinical trial processes

• Experience with user access management frameworks and segregation of duties in a regulated environment

• Hands-on experience with computer system validation (CSV), including authoring and executing IQ/OQ/PQ and user acceptance test documentation

• Familiarity with GxP, ICH-GCP, and 21 CFR Part 11 compliance requirements

• Strong vendor management skills and experience coordinating with Medidata support

• Excellent troubleshooting, analytical, and stakeholder communication skills

• Medidata certifications (e.g., Rave Study Builder, Rave Administrator) strongly preferred

• Ability to work fully remote and provide consistent coverage during US Eastern Standard Time (EST) business hours

Why Join the Atlas A-Team of Consultants

• Opportunity — Atlas has deep life sciences industry roots and a reputation for delivering superior consulting talent

• Meaningful Work — Support initiatives that help improve patient outcomes and advance healthcare innovation

• Culture — We are proactive, highly accountable, and collaborative

• Stability — Atlas has been delivering consulting excellence for over 25 years

• Client Impact — Work alongside leading life sciences organizations on strategic and transformative initiatives

• Career Growth — Opportunity to build a long-term consulting career with strong leadership support

• Collaborative Environment — Join a high-performing team built on mutual trust, respect, and partnership

Send Us Your Resume

If you are interested in joining a high-growth consulting organization supporting innovative life sciences initiatives, we encourage you to apply and share your experience with us.

We Are an Equal Opportunity Employer

Atlas is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, genetics, disability, age, veteran status, or any other protected characteristic in accordance with applicable law.