Note: The job is a remote job and is open to candidates in USA. Deloitte is seeking an experienced Clinical Data AMS Senior Consultant to support its Clinical Data Analytics Technology & Operations organization. The role administers and maintains SAS Grid and related clinical and regulatory platforms, leads incident and change management, manages validation and compliance activities, and supports platform upgrades, audits, and managed services delivery.
Responsibilities
- 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
Skills
- * Ability to work independently and collaborate as part of a team
- * Effective written and verbal communication skills
- * Meticulous attention to detail and quality of work product
- * Ability to build and sustain professional relationships
- * Ability to lead projects or workstreams
- * Ability to manage and prioritize multiple tasks in a fast-paced and dynamic environment
- * Strong interpersonal skills and professional demeanor
- * Ability to meet deadlines
- * Ability to provide clear guidance to others
- * 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
- * Experience with Linux and Windows server administration in support of grid/application environments
- * 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
- * Ability to travel 10%, on average, based on the work you do and the clients and industries/sectors you serve
- * Role is remote
- * Experience with CDISC standards (SDTM/ADaM) as they relate to downstream SAS programming environments
- * SAS Certified Platform Administrator or SAS Certified Deployment Specialist credential
- * Familiarity with supplier qualification management and third-party audit management modules within QMS platforms
- * ServiceNow or equivalent ITSM tool experience for ticketing and change management
- * Experience supporting regulatory submissions (FDA/EMA) from a systems/platform readiness perspective
Benefits
- Long-term, remote client service delivery
- You may also be eligible to participate in a discretionary annual incentive program, subject to the rules governing the program, whereby an award, if any, depends on various factors, including, without limitation, individual and organizational performance.
- Opportunities to build new skills, take on leadership opportunities and connect and grow through mentorship.
Company Overview
Company H1B Sponsorship