Business Analyst, Veeva Migration

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist in the planning, execution, validation, and stabilization of Veeva Vault eTMF migration projects post-go-live.

• Collaborate with Clinical Operations, TMF, Quality, IT, and vendor teams to collect, analyze, and document both business and functional requirements.

• Aid in migration planning, which includes defining the scope, mapping source-to-target, reviewing metadata, classifying documents, managing audit trails, and ensuring migration readiness.

• Convert business requirements into functional specifications, user stories, process flows, test scenarios, and traceability documentation.

• Work alongside technical teams on data extraction, transformation, loading, reconciliation, and verification of eTMF documents and their associated metadata.

• Provide support for IQ/OQ/UAT planning, develop test scripts, assist with execution, track defects, and review evidence for GxP systems.

• Participate in discussions regarding Veeva Vault configuration, addressing aspects such as document types, lifecycles, workflows, roles, permissions, metadata, Expected Document Lists, and alignment with the TMF Reference Model.

• Perform data quality assessments and help resolve issues related to duplicate records, missing metadata, mapping inconsistencies, picklist mismatches, and document discrepancies.

• Organize migration dry runs, UAT sampling, production migration verification, and obtain business sign-off.

• Keep documentation updated for requirements, migration specifications, test evidence, defect logs, support plans, and operational readiness materials.

• Facilitate go-live activities, hypercare support, transition to support, and post-migration issue triage to ensure continuity of operations and user acceptance.

⛳️ Requirements

• A minimum of 5 years of experience as a Business Analyst, Functional Analyst, Technical Analyst, or Techno-Functional Analyst focused on clinical, regulatory, or GxP applications.

• Practical experience with Veeva Vault Clinical Operations, ideally Veeva eTMF, CTMS, Study Startup, or Site Connect.

• Demonstrated experience in supporting eTMF migration initiatives, which includes document migration, metadata mapping, source-to-target reconciliation, and validation testing.

• Strong grasp of Trial Master File processes, TMF Reference Model, document completeness, inspection readiness, audit trails, and management of the clinical document lifecycle.

• Experience in regulated life sciences settings with an understanding of GxP, 21 CFR Part 11, Annex 11, validation, change control, and data integrity standards.

• Capability to document functional requirements, business process flows, data mapping guidelines, test cases, traceability matrices, and deliverables related to migration.

• Experience with UAT, defect management, production readiness, go-live planning, and hypercare support.

• Excellent analytical, problem-solving, communication, and stakeholder management abilities.

• Background in migrating content from legacy eTMF systems like 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 platforms for managing requirements, testing, change management, and defect tracking.

• Understanding of clinical trial operations, study-level data, site documents, monitoring documents, CRO user models, and expectations for inspection readiness.

• A Bachelor’s degree in Life Sciences, Computer Science, Information Systems, or a related discipline; equivalent experience may also be considered.

🏝️ Benefits

• High growth potential and a dynamic environment with a focus on people.

• Competitive salary plus performance-based incentive programs.

• Employer-sponsored Life, Short-Term, and Long-Term Disability Insurance.

• Comprehensive Medical, Dental & Vision insurance options.

• Flexible Spending Account (FSA), Dependent Care Account (DCARE), and Commuter Benefits.

• Additional benefits including Supplemental Life, Hospital, Critical Illness, and Legal Insurance.

• Health Savings Account (HSA) available.

• 401(k) Retirement Plan with employer matching benefits.

• Generous Paid Time Off (with rollover option) and holidays.

• As-needed sick leave.

• Tuition reimbursement for further education.

• Engaging team social activities (we value having fun!).

• Employee recognition programs.

• Employee referral incentives.

• Paid parental leave and bereavement support.