
501 - 1000 employees
💼 Consulting
🏭 Manufacturing
🍽️ Food & Beverage
Consulting • Manufacturing • Food & Beverage
Verista, Inc. is a service provider specializing in solutions for the life sciences, biotech, pharmaceuticals, and medical devices sectors. They offer expertise in areas such as commissioning, qualification, and validation, vision and systems integration, technology solutions, data analytics and strategy, cybersecurity, digital transformation, regulatory compliance, and infrastructure management. Verista excels in providing managed services, program and project management, and digital strategy to ensure quality and compliance throughout the product lifecycle. Their focus on personalized engagement and effective communication makes them a favored partner among top life sciences companies worldwide.
🔥 0 minutes ago
🇺🇸 United States – Remote
💵 $69.3k - $104.4k / year
⏰ Full Time
🟡 Mid-level
🟠 Senior
🧐 Business Analyst
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501 - 1000 employees
💼 Consulting
🏭 Manufacturing
🍽️ Food & Beverage
Consulting • Manufacturing • Food & Beverage
Verista, Inc. is a service provider specializing in solutions for the life sciences, biotech, pharmaceuticals, and medical devices sectors. They offer expertise in areas such as commissioning, qualification, and validation, vision and systems integration, technology solutions, data analytics and strategy, cybersecurity, digital transformation, regulatory compliance, and infrastructure management. Verista excels in providing managed services, program and project management, and digital strategy to ensure quality and compliance throughout the product lifecycle. Their focus on personalized engagement and effective communication makes them a favored partner among top life sciences companies worldwide.
• Support the planning, execution, validation, and post-go-live stabilization of Veeva Vault eTMF migration initiatives. • Partner with Clinical Operations, TMF, Quality, IT, and vendor teams to gather, analyze, and document business and functional requirements. • Support migration planning, including scope definition, source-to-target mapping, metadata review, document classification, audit trail handling, and migration readiness. • Translate business requirements into functional specifications, user stories, process flows, test scenarios, and traceability documentation. • Collaborate with technical teams on data extraction, transformation, loading, reconciliation, and verification of eTMF documents and metadata. • Assist with IQ/OQ/UAT planning, test script development, execution support, defect tracking, and evidence review for GxP systems. • Support Veeva Vault configuration discussions covering document types, lifecycles, workflows, roles, permissions, metadata, Expected Document Lists, and TMF Reference Model alignment. • Conduct data quality checks and support resolution of duplicate records, missing metadata, mapping inconsistencies, picklist mismatches, and document discrepancies. • Coordinate migration dry runs, UAT sampling, production migration verification, and business sign-off. • Maintain requirements documentation, migration specifications, test evidence, defect logs, support plans, and operational readiness materials. • Support go-live, hypercare, transition to support, and post-migration issue triage to ensure business continuity and user adoption.
• 5+ years of experience as a Business Analyst, Functional Analyst, Technical Analyst, or Techno-Functional Analyst supporting clinical, regulatory, or GxP applications. • Hands-on experience with Veeva Vault Clinical Operations, preferably Veeva eTMF, CTMS, Study Startup, or Site Connect. • Proven experience supporting eTMF migration projects, including document migration, metadata mapping, source-to-target reconciliation, and validation testing. • Strong understanding of Trial Master File processes, TMF Reference Model, document completeness, inspection readiness, audit trails, and clinical document lifecycle management. • Experience working in regulated life sciences environments with knowledge of GxP, 21 CFR Part 11, Annex 11, validation, change control, and data integrity expectations. • Ability to document functional requirements, business process flows, data mapping rules, test cases, traceability matrices, and migration-related deliverables. • Experience supporting UAT, defect management, production readiness, go-live planning, and hypercare support. • Strong analytical, problem-solving, communication, and stakeholder management skills. • Experience migrating content from legacy eTMF systems such as IQVIA eTMF or other clinical document repositories into Veeva Vault. • Familiarity with Veeva Vault Loader, migration-center tools, bulk loading processes, and document migration utilities. • Experience with ALM, Jira, ServiceNow, or similar tools for requirements, testing, change management, and defect tracking. • Knowledge of clinical trial operations, study-level data, site documents, monitoring documents, CRO user models, and inspection readiness expectations. • Bachelor’s degree in Life Sciences, Computer Science, Information Systems, or a related field; equivalent experience may be considered.
• High growth potential and fast-paced organization with a people-focused culture • Competitive pay plus performance-based incentive programs • Company-paid Life, Short-Term, and Long-Term Disability Insurance. • Medical, Dental & Vision insurances • FSA, DCARE, Commuter Benefits • Supplemental Life, Hospital, Critical Illness and Legal Insurance • Health Savings Account • 401(k) Retirement Plan (Employer Matching benefit) • Paid Time Off (Rollover Option) and Holidays • As Needed Sick Time • Tuition Reimbursement • Team Social Activities (We have fun!) • Employee Recognition • Employee Referral Program • Paid Parental Leave and Bereavement
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