Veeva eTMF Migration Analyst for Clinical Ops

Verista, Inc.; United States; Teletrabalho; USD 69 000 - 104 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Competitive pay

401(k) plan

Health, Dental, Vision insurance

Paid Time Off

Resumo da oferta

Verista is seeking a Business Analyst for Veeva migration within Clinical Operations. You will gather requirements, map data, and support validation and go-live for eTMF migrations to Veeva Vault, collaborating with QA, IT, and vendors.

The role requires 5+ years in regulated life sciences, hands-on Veeva Vault Ops experience, and strong analytical and stakeholder skills. US-based role with competitive compensation.

Qualificações

• 5+ years of experience as a Business Analyst, Functional Analyst, Technical Analyst, or Techno-Functional Analyst in clinical, regulatory or GxP apps.
• 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, reconciliation, and validation testing.
• Strong understanding of TMF processes, TMF Reference Model, document completeness, inspection readiness, audit trails, and lifecycle management.
• Experience in regulated life sciences with knowledge of GxP, 21 CFR Part 11, Annex 11, validation, change control, and data integrity.
• Document functional requirements, business processes, data mapping, test cases, traceability.
• Experience supporting UAT, defect management, production readiness, go-live planning, and hypercare.
• Strong analytical, problem-solving, communication, and stakeholder management skills.

Responsabilidades

• Partner with Clinical Operations, TMF, Quality, IT, and vendor teams to gather and document requirements for Veeva eTMF migration.
• Support migration planning including scope, mapping, metadata review, classification, audit trails, and readiness activities.
• Translate requirements into specifications, user stories, process flows, test scenarios, and traceability docs.
• Collaborate with technical teams on data extraction, transformation, loading, reconciliation, and verification of eTMF data and metadata.
• Assist with IQ/OQ/UAT planning, test scripts, execution support, defect tracking, and evidence review for GxP systems.
• Support configuration discussions on document types, lifecycles, workflows, roles, permissions, metadata, and TMF alignment.
• Conduct data quality checks and resolve issues like duplicates, missing metadata, mapping mismatches, and document-level discrepancies.
• Coordinate migration dry runs, UAT sampling, production migration verification, and business sign-off.
• Prepare and maintain deliverables: requirements, migration specs, test evidence, defect logs, support plans, and readiness materials.
• Support go-live, hypercare, transition to support, and post-migration issue triage.

Conhecimentos

Analytical thinking

Problem-solving

Communication

Stakeholder management

Formação académica

Bachelor's degree in Life Sciences, Computer Science, Information Systems or related field

Ferramentas

Veeva Vault Clinical Operations

Veeva eTMF

Descrição da oferta de emprego

Verista is seeking a Business Analyst for Veeva migration within Clinical Operations. You will gather requirements, map data, and support validation and go-live for eTMF migrations to Veeva Vault, collaborating with QA, IT, and vendors.

The role requires 5+ years in regulated life sciences, hands-on Veeva Vault Ops experience, and strong analytical and stakeholder skills. US-based role with competitive compensation.