Senior Clinical Data Standards Jobs in Rochester, NY

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

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 (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).

Work you'll do/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. The successful candidate would possess these 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

The Team 

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 lifecycles 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.

Our Industry Solutions offering provides verticalized solutions that transform how clients sell products, deliver services, generate growth, and execute mission-critical operations. We deliver integrated business expertise with scalable, repeatable technology solutions specifically engineered for each sector.

Qualifications Required

• 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

Preferred

• 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.

The wage range for this role takes into account the wide range of factors that are considered in making compensation decisions including but not limited to skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Deloitte, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current range is $120,200 - $140,000.

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.

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

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 (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).

Work you'll do/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. The successful candidate would possess these 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

The Team 

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 lifecycles 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.

Our Industry Solutions offering provides verticalized solutions that transform how clients sell products, deliver services, generate growth, and execute mission-critical operations. We deliver integrated business expertise with scalable, repeatable technology solutions specifically engineered for each sector.

Qualifications Required

• 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 ...