Clinical Data Business Systems Analyst

seeking a Senior Clinical Data Business Systems Analyst to support Diverse SCE workstreams contributing to the definition, documentation, and delivery of business processes, system capabilities, and operational solutions in a regulated clinical environment. This role will be on-site and located in Indianapolis, IN. NO remote option. 6-12 months +, * Gather, analyze, and document business, functional, and system requirements.

• Develop current-state and future-state workflows and process maps using tools such as Lucid chart, Visio, or Figma.
• Translate business needs into clear documentation for technical teams, vendors, and implementation partners.
• Create and maintain system documentation, user documentation, SOP-aligned workflows, and training inputs.
• Partner with business and technical stakeholders to identify process gaps, risks, dependencies, and improvement opportunities.
• Support validated systems through clear requirements, test planning, documentation, and audit-ready artifacts.
• Contribute to user-focused system design, ensuring solutions align to operational workflows and usability needs.
• Operate independently in a fast-paced, regulated environment, bringing structure and clarity to ambiguous problems.
• Ensure solutions align with data governance, security, and compliance expectations.

This role requires strong business systems analysis skills, the ability to work across cross-functional stakeholders, and comfort operating in complex, regulated systems. Depending on assignment, the analyst may focus on study workflows and user experience, data products and automation, or study data access and movement, while applying consistent strengths in requirements gathering, documentation, and solution enablement.

The ideal candidate will have clinical experience with proven ability to translate business needs into clear, structured requirements and workflows that support scalable, compliant, and user-focused solutions., * 5-7 years of experience in business systems analysis, IT systems support, or related roles.

• Strong experience gathering and documenting business and system requirements.
• Strong experience with process mapping and workflow documentation.
• Experience creating clear, high-quality system and process documentation.
• Ability to work across technical and non-technical stakeholders.
• Experience supporting complex systems in regulated or highly controlled environments.

Relevant Tools:

• Process Mapping: Lucid chart, Visio, or Figma.
• Documentation: Jira, Confluence, Veeva (a must)
• File Systems/Structures: POSIX, Windows, AWS FSx & S3
• AI tools: CoPilot, Claude

Attributes:

• Self-starter with the ability to work independently, learn new domains quickly, and navigate ambiguity.
• Proven Learning agility with strong written and verbal communication skills with high attention to detail

Workstream Qualifications

• Study Workflows, User Experience & Audit

• Workflow design, usability, and process standardization

• Validated system documentation and audit readiness

• Test planning, execution support, and training enablement

• UI/ UX Design Design

• Data Products, Visualization & Automation

• Definition of business-facing data products

• Analytics, reporting, visualization, and automation use cases

• Turning business questions into scalable data solutions

• Study Data Storage, Access & Migration

• Study data access models, mapping, and governance

• Large scale System/Data Migration experience, preferably experience leading the migration

• Enterprise search engines at scale with security/permissions to results content

• Documentation of data movement, controls, and dependencies

• Experience working within clinical development or life sciences environments.

• Familiarity with SAS data sets, file systems, and statistical programming environments, with SAS/R code and/or SQL knowledge preferred

• Familiarity with core clinical systems such as EDC, CTMS, and central lab data platforms.

• Exposure to the Veeva clinical ecosystem (e.g., Vault Clinical, CDMS, Study Startup).

• Working knowledge of clinical data standards (e.g., CDISC SDTM and ADaM).

• Understanding of regulated system practices, including GxP, 21 CFR Part 11, and inspection-ready documentation.

• Awareness of clinical data privacy and security requirements (e.g., HIPAA, GDPR).

• Experience supporting or integrating statistical computing or clinical analytics environments.

• Familiarity with regulatory submission workflows and traceable, reproducible clinical data processes.

• Clinical research and pharma environments