Clinical Data AMS Sr. Consultant

Clinical Data AMS Senior Consultant

Are you an experienced, passionate pioneer in technology who wants to work in a collaborative environment? As an experienced Clinical Data AMS Senior Consultant you will have the ability to share new ideas and collaborate on projects as a consultant without the extensive demands of travel. If so, consider an opportunity with Deloitte under our Project Talent Model. Project Talent Model (PTM) is a talent model that is tailored specifically for long-term, remote client service delivery.

Recruiting for this role ends on 10/1/2026

The Clinical Data Analytics (CDA) AMS Lead will serve as the primary functional and operational expert for the Clinical Data Analytics (CDA) technology portfolio, with primary emphasis on SAS Grid Administration supporting biostatistics and real-world data (RWD) science operations. This role owns the health, stability, and compliance posture of a suite of clinical and regulatory R&D platforms - including Axway Secure Transport (ST), eClinical Elluminate, Eclipse (medical coding), and EAST - across the full engagement lifecycle: implementation, configuration, validation, and steady-state managed services.

The AMS Lead acts as the escalation point for platform issues, drives root-cause resolution, and ensures all supported systems remain inspection-ready in accordance with global regulatory standards (GxP, 21 CFR Part 11, GDPR/HIPAA as applicable).

As a Clinical Data AMS Senior Consultant, you will provide own day-to-day administration, monitoring, patching, upgrades, troubleshooting and performance tuning of the SAS Grid environment (grid nodes, metadata server, workspace/stored process servers), ensuring high availability for biostatistical programming and RWE workloads. Manage configuration, patching, upgrades, and troubleshooting for Axway Secure Transport (ST), ensuring secure, reliable file transfer for clinical data exchange with CROs, labs, and regulatory partners.

Provide operational and functional support for eClinical Elluminate, including data review workflows, listings/reports configuration, and integration touchpoints with upstream/downstream clinical systems. Support EAST (Trial design and simulation platform) configuration, access provisioning, and issue triage. Lead incident, problem, and change management across all supported platforms - triaging tickets, performing root-cause analysis, and driving permanent fixes within SLA. Manage installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) activities, and maintain validation documentation (URS, FRS, test scripts, traceability matrices) for all platform changes.

Coordinate patching, upgrades, DR/backup testing, and environment refreshes (Prod/UAT/Dev) in line with change control procedures. Ensure ongoing compliance with GxP, Part 11, data integrity (ALCOA+), and audit-readiness across all systems; support internal/external audits and regulatory inspections.

Manage access control, user provisioning/de-provisioning, and periodic access reviews per SOX/GxP requirements. Develop and maintain SOPs, runbooks, knowledge base articles, and platform architecture documentation. Monitor capacity, licensing, and vendor SLAs; escalate and manage vendor relationships (SAS, Axway, Elluminate, Eclipse vendors) as needed.

Conduct root cause analysis (RCA) for recurring incidents and implement corrective and preventive actions in coordination with Quality and IT teams. Support validation activities including IQ/OQ/PQ execution, traceability matrix development, and preparation of GxP-compliant documentation. Participate in go-live readiness activities, cutover planning, hypercare support, and post-implementation review. Lead teams comprising consultants and analysts and drive delivery within the quality and compliance workstream.

Maintain comprehensive documentation including runbooks, SOPs, functional specifications, validation artefacts, and change management records.

You will be part of the Clinical Data Analytics (CDA) Technology & Operations organization, which enables biostatistics, clinical data management, and real-world evidence functions with reliable, compliant, and scalable technology platforms. The team operates at the intersection of IT infrastructure, clinical operations, and quality/regulatory compliance, partnering closely with global business and technology stakeholders to support end-to-end clinical trial data life cycles from data capture and coding through statistical analysis and submission-ready outputs.

The team follows a managed-services model with defined SLAs, on-call rotation for critical platform support, and a strong culture of continuous improvement and regulatory rigor.

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