Job Summary:
The CTMS to Veeva Migration Lead will own the end-to-end migration of clinical trial management data from legacy clinical systems into a new, standalone Veeva Vault Clinical environment as part of a MedTech business separation. The role will be responsible for defining the migration strategy, leading source-to-target mapping, managing data extraction and transformation, overseeing data cleansing and reconciliation, and coordinating cutover and post-migration activities. The candidate will work closely with clinical operations, IT, quality, and Veeva services teams to ensure a compliant and successful migration.
Key Responsibilities:
• Define the migration strategy and plan, including scope, in-flight versus closed studies, cutover approach, and sequencing aligned with the business separation timeline.
• Lead source-to-target mapping for studies, countries, sites, investigators, subjects, visits, milestones, monitoring events, issues, and deviations.
• Manage extract, transform, and load (ETL) cycles using Vault Loader, Vault APIs, and migration tools.
• Own migration dry runs, defect tracking, and resolution activities.
• Drive data cleansing and entity separation to ensure that only the carved-out business's studies, sites, and records are migrated.
• Lead reconciliation and migration verification, including record counts, field-level checks, audit trail integrity, and attachment validation.
• Coordinate cutover, hypercare, and decommissioning handover activities with clinical operations, IT, quality, and Veeva services teams.
• Manage dependencies involving eTMF, EDC, safety, and finance integrations affected by the CTMS migration.
• Provide migration status updates, identify risks, and coordinate resolutions with program leadership and stakeholders.
Required Qualifications:
• 10+ years of experience in clinical systems, including 5+ years of experience with Veeva Vault Clinical.
• Experience leading at least 2 CTMS migrations into Veeva Vault CTMS as the accountable migration lead, including at least one migration involving 100+ studies or multiple regions.
• Working knowledge of the Vault Clinical Operations data model and object relationships across CTMS, eTMF, and Study Startup.
• Hands-on experience with Vault Loader, Vault API, VQL, and migration-mode data loads.
• Strong SQL and ETL skills.
• Experience delivering migrations in GxP environments, including preparation of migration plans, mapping specifications, verification protocols, and migration summary reports.
• Strong knowledge of 21 CFR Part 11, EU Annex 11, ICH E6 GCP, and ALCOA+ data integrity requirements.
• Strong client-facing communication skills, with the ability to lead workshops and independently report project status and risks to program leadership.
Preferred Qualifications:
• Experience with divestiture, carve-out, or Vault-to-Vault separation programs.
• Experience in medical device clinical environments, including ISO 14155 and IDE studies under 21 CFR 812.
• Veeva Vault Administrator certification.
• Experience with third-party migration tools.
