Clinical Data AMS Sr. Consultant

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.

Deloitte is committed to providing reasonable accommodations for people with disabilities. If you require a reasonable accommodation to participate in the recruiting process, please direct your inquiries to the Global Call Center (GCC) at USTalentCICInbox@deloitte.com.

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Benefits

At Deloitte, we know that great people make a great organization. We value our people and offer employees a broad range of benefits. Learn more about what working at Deloitte can mean for you.

Our people and culture

Our inclusive culture empowers our people to be who they are, contribute their unique perspectives, and make a difference individually and collectively. It enables us to leverage different ways of thinking, ideas, and perspectives, and bring more creativity and innovation to help solve our clients' most complex challenges. This makes Deloitte one of the most rewarding places to work.

Our purpose

Deloitte's purpose is to make an impact that matters for our people, clients, and communities. At Deloitte, purpose is synonymous with how we work every day. It defines who we are. Our purpose comes through in our work with clients that enables impact and value in their organizations, as well as through our own investments, commitments, and actions across areas that help drive positive outcomes for our communities. Learn more.

Professional development

From entry-level employees to senior leaders, we believe there's always room to learn. We offer opportunities to build new skills, take on leadership opportunities and connect and grow through mentorship. From on-the-job learning experiences to formal development programs, our professionals have a variety of opportunities to continue to grow throughout their career.

As used in this posting, "Deloitte" means Deloitte Consulting LLP, a subsidiary of Deloitte LLP. Please see https://www.deloitte.com/us/about for a detailed description of the legal structure of Deloitte LLP and its subsidiaries.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or protected veteran status, or any other legally protected basis, in accordance with applicable law.

Qualified applicants with criminal histories, including arrest or conviction records, will be considered for employment in accordance with the requirements of applicable state and local laws, including the Los Angeles County Fair Chance Ordinance for Employers, City of Los Angeles's Fair Chance Initiative for Hiring Ordinance, San Francisco Fair Chance Ordinance, and the California Fair Chance Act. See notices of various fair chance hiring and ban-the-box laws where available. Fair Chance Hiring and Ban-the-Box Notices | Deloitte US Careers

Requisition code: 364229

Job ID 364229

Client-provided location(s): Milwaukee, WI, Atlanta, GA, Kansas City, MO, Columbus, OH, Houston, TX, Huntsville, AL, Boston, MA, San Antonio, TX, Fort Worth, TX, Omaha, NE, Birmingham, AL, Detroit, MI, Seattle, WA, Honolulu, HI, Indianapolis, IN, San Diego, CA, Pittsburgh, PA, San Francisco, CA, Philadelphia, PA, New York, NY, Portland, OR, Cleveland, OH, Charlotte, NC, Raleigh, NC, Sacramento, CA, Richmond, VA, Baltimore, MD, Minneapolis, MN, Washington, DC, Tampa, FL, Las Vegas, NV, Los Angeles, CA, Austin, TX, Grand Rapids, MI, Nashville, TN, Miami, FL, Dallas, TX, New Orleans, LA, Denver, CO, Chicago, IL, Memphis, TN, Des Moines, IA, Salt Lake City, UT, Boise, ID, Princeton, NJ, Colorado Springs, CO, Cincinnati, OH, Buffalo, NY, Jacksonville, FL, Hartford, CT, Louisville, KY, Tulsa, OK, Tallahassee, FL, Fresno, CA, San Jose, CA, Rock Island, IL, Midland, MI, Tempe, AZ, Wichita, KS, Arlington, VA, Bellevue, WA, Jersey City, NJ, McLean, VA, Lake Mary, FL, Playa Vista, CA, Costa Mesa, CA, Hendersonville, TN, Dayton, OH, Chandler, AZ, East Lansing, MI, Monterey, CA, Mechanicsburg, PA, Jericho, NY, Darien, CT, Westlake, TX, Morristown, NJ, Gunnison, CO, Rochester, MA

Job ID: Deloitte-364229

Employment Type: OTHER

Posted: 2026-08-26T23:31:17