Business Process Engineer - CTMS

Business Process Engineer - CTMS 

Clinical Trial Operations & CTMS (Veeva/Siebel)

Wilmington - DE - Onsite

 

We are seeking an experienced Business Process Engineer with a strong background in Clinical Trial Operations to join our Life Sciences R&D team. This role will lead end-to-end business process assessment, design, and optimization initiatives across clinical operations, with a focus on Clinical Trial Management System (CTMS) capabilities — preferably Veeva CTMS or Siebel Clinical. The ideal candidate bridges business process expertise with system configuration and regulatory compliance knowledge to drive efficient, compliant, and scalable clinical trial operations.

• Perform end-to-end business process assessment and design across all in-scope business units and stakeholder roles within Clinical Trial Operations.
• Facilitate workshops and stakeholder interviews to capture current-state (“as-is”) processes and design future-state (“to-be”) processes.
• Create clear, structured business process maps (e.g., swimlane diagrams, BPMN) to document workflows across clinical trial functions.
• Translate business requirements into well-formed User Stories and functional/technical requirements to support Veeva CTMS configuration.
• Partner with IT, Business Analysts, and system configuration teams to ensure CTMS design aligns with defined business processes and organizational needs.
• Translate approved business processes into Standard Operating Procedures (SOPs) and Work Instructions (WIs), ensuring alignment with regulatory expectations.
• Support Computer System Validation (CSV) activities and ensure process documentation aligns with 21 CFR Part 11 and other applicable Life Sciences regulations.
• Identify process gaps, inefficiencies, and risks, and recommend improvements to enhance quality, compliance, and operational efficiency.
• Collaborate cross-functionally with Clinical Operations, Quality, Regulatory, and IT teams throughout the process design and system implementation lifecycle.
• Communicate process designs, requirements, and recommendations clearly to both technical and non-technical stakeholders, including leadership.

• Demonstrated experience in Life Sciences R&D, predominantly within Clinical Trial Operations.
• Strong familiarity or hands-on working experience with a CTMS application — Veeva CTMS or Siebel Clinical strongly preferred.
• Proven experience conducting business process assessments and designing end-to-end processes across multiple business units and roles.
• Working knowledge of business process mapping techniques and tools (e.g., BPMN, Visio, Lucidchart, or similar).
• Demonstrated experience creating User Stories / functional requirements for system configuration, ideally within Veeva.
• Proven ability to translate business processes into SOPs and Work Instructions.
• Strong knowledge of Life Sciences regulations, particularly 21 CFR Part 11, and experience with Computer System Validation (CSV) processes.
• Excellent written and verbal communication skills, with the ability to engage stakeholders at all levels of the organization.

• Bachelor's degree in Life Sciences, Business, Information Systems, or a related field (or equivalent practical experience).
• Experience with Veeva Vault CTMS configuration, data model, or administration.
• Prior experience in a consulting, business analyst, or process improvement role within a regulated Life Sciences environment.
• Familiarity with GxP environments and change control / validation lifecycle documentation.
• Process improvement or business analysis certifications (e.g., Lean Six Sigma, CBAP) are a plus.

• Analytical thinking and structured problem-solving.
• Strong stakeholder management and facilitation skills.
• Attention to detail with a quality- and compliance-first mindset.
• Ability to work independently and manage multiple work streams in a fast-paced environment.