Clinical Data AMS Sr. Consultant

Position Summary

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 (RWE) 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).

Work You'll Do/Responsibilities

• 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.
• Career Development and Professional Growth
• Develop and maintain SOPs, runbooks, knowledge base articles, and platform architecture documentation.
• Maintain comprehensive documentation including runbooks, SOPs, functional specifications, validation artefacts, and change management records.
• 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.

Qualifications

• 6+ years of IT application support/administration experience in a pharmaceutical, biotech, or CRO environment, with 3+ years hands-on SAS Grid Administration.
• Experience supporting clinical/regulatory platforms in a GxP/validated environment, including change control, CSV (Computer System Validation), and audit support.
• Hands-on experience with Axway Secure Transport (ST) or equivalent secure managed file transfer (MFT) tools.
• Familiarity with GxP quality management concepts including 21 CFR Part 11, Annex 11, computerised system validation (CSV), and IQ/OQ/PQ documentation standards.
• Experience with Incident Management, Problem Management, and Change Management following ITSM/ITIL frameworks.
• Proficiency with ServiceNow and JIRA for ticket management, SLA tracking, and Agile project delivery.
• S/B.E / B.Tech / M.C.A. / M.Sc (CS) degree or equivalent experience.
• Limited immigration sponsorship may be available.