Project lead

RIM Migration PM – TrackWise to RIM

Zensar Technologies | Healthcare & Life Sciences Practice Experience: 10+ Years (Project Lead) | Focus: Data Migration Only (No Configuration / No Development)

Role Overview

Zensar Technologies is seeking a senior RIM Migration Specialist to lead data migration engagements transitioning clients from legacy TrackWise environments to modern Regulatory Information Management platforms — primarily Veeva Vault RIM. This is a pure migration leadership role: the mandate is scoping, planning, executing, and governing the movement of regulatory data and documents — not system configuration or development.

The right candidate has seen TrackWise up close — its data model, its quirks, its export limitations — and knows exactly what it takes to land regulatory content cleanly in a Vault RIM target environment. They bring project leadership credibility, deep data quality instincts, and the ability to hold both client stakeholders and technical teams accountable to a migration plan.

Key Responsibilities

Migration Strategy & Planning

• Own the end-to-end migration strategy for TrackWise-to-RIM engagements, covering scope definition, data inventory, migration approach (big bang vs. phased), and cutover planning.
• Lead source system analysis of TrackWise instances — document data structures, object relationships, document types, metadata schemas, and known data quality issues.
• Define and baseline migration scope in alignment with client regulatory operations, IT, and compliance teams.
• Produce migration project plans, RAID logs, dependency maps, and milestone trackers.

Data Profiling & Mapping

• Drive source-to-target data mapping between TrackWise entities and Veeva Vault RIM objects (Submissions, Registrations, Submission Archive, Documents).
• Lead data profiling exercises to identify completeness gaps, duplicate records, legacy taxonomy mismatches, and orphaned document sets.
• Define transformation rules, mapping decisions, and exception handling logic in collaboration with functional and configuration teams.
• Maintain the migration mapping specification document as a living project artifact.

Migration Execution Governance

• Govern migration execution cycles — extract, transform, load (ETL) — in coordination with technical migration teams; no hands-on ETL coding required.
• Define and enforce data quality thresholds, reconciliation checkpoints, and go/no-go criteria for each migration wave.
• Review and sign off on migration run reports, reconciliation logs, and exception registers.
• Chair migration steering meetings; escalate blockers and risks to programme leadership promptly.

Validation & Compliance

• Ensure the migration approach and execution satisfy GxP, 21 CFR Part 11, and Annex 11 requirements for validated systems.
• Oversee preparation of migration-related validation deliverables: Migration Strategy Document, Data Migration Plan, Migration Test Scripts, OQ/PQ evidence, and Migration Closure Report.
• Coordinate with client QA/validation teams on IQ/OQ/PQ protocols and audit trail requirements for migrated data.

Stakeholder & Client Management

• Act as the single point of accountability for migration workstream delivery on the client side.
• Facilitate working sessions with regulatory affairs, RA operations, IT, and compliance teams to resolve mapping conflicts and migration exceptions.
• Communicate migration progress, risks, and decisions clearly to both technical and non-technical audiences.
• Manage client expectations on data remediation effort, migration timelines, and legacy data quality realities.

Required Skills & ExperienceSkill / DomainExpectationTrackWiseDeep familiarity with TrackWise data model, document types, submission/registration objects, and export mechanismsVeeva Vault RIMFunctional understanding of Vault RIM objects, document structures, and metadata model (migration context, not configuration)Data Migration LeadershipProven track record leading large-scale data migration programmes in life sciences — project lead, not team memberData Mapping & ProfilingHands-on experience authoring source-to-target mapping specs, transformation rules, and exception handling frameworksGxP / CSV ComplianceSolid understanding of validated system migration requirements; able to own or review migration validation deliverablesStakeholder ManagementConfident in client-facing delivery; capable of managing senior regulatory and IT stakeholders through ambiguityDocumentationMeticulous; can produce and govern migration artefacts that will withstand regulatory inspectionToolsExcel / data profiling tools for mapping; JIRA or equivalent for issue tracking; SharePoint / Vault for document managementPreferred Qualifications

• Prior experience migrating from TrackWise Digital (Sparta Systems) specifically — not just generic EDMS or QMS migrations.
• Exposure to other legacy RIM or regulatory document systems: DOCUMENTUM, OpenText, Pilgrim SmartSolve, or homegrown RA document repositories.
• Familiarity with eCTD structure and regulatory submission dossier organisation — aids mapping decisions for Submissions Archive migrations.
• Experience working alongside Veeva Professional Services or a certified Veeva SI partner on Vault RIM implementations.
• PMP, PRINCE2, or equivalent project management certification.
• Knowledge of IDMP data standards and their relevance to registration data migration.

ResponsibilitiesKey Responsibilities

Migration Strategy & Planning

• Own the end-to-end migration strategy for TrackWise-to-RIM engagements, covering scope definition, data inventory, migration approach (big bang vs. phased), and cutover planning.
• Lead source system analysis of TrackWise instances — document data structures, object relationships, document types, metadata schemas, and known data quality issues.
• Define and baseline migration scope in alignment with client regulatory operations, IT, and compliance teams.
• Produce migration project plans, RAID logs, dependency maps, and milestone trackers.

Data Profiling & Mapping

• Drive source-to-target data mapping between TrackWise entities and Veeva Vault RIM objects (Submissions, Registrations, Submission Archive, Documents).
• Lead data profiling exercises to identify completeness gaps, duplicate records, legacy taxonomy mismatches, and orphaned document sets.
• Define transformation rules, mapping decisions, and exception handling logic in collaboration with functional and configuration teams.
• Maintain the migration mapping specification document as a living project artifact.

Migration Execution Governance

• Govern migration execution cycles — extract, transform, load (ETL) — in coordination with technical migration teams; no hands-on ETL coding required.
• Define and enforce data quality thresholds, reconciliation checkpoints, and go/no-go criteria for each migration wave.
• Review and sign off on migration run reports, reconciliation logs, and exception registers.
• Chair migration steering meetings; escalate blockers and risks to programme leadership promptly.

Validation & Compliance

• Ensure the migration approach and execution satisfy GxP, 21 CFR Part 11, and Annex 11 requirements for validated systems.
• Oversee preparation of migration-related validation deliverables: Migration Strategy Document, Data Migration Plan, Migration Test Scripts, OQ/PQ evidence, and Migration Closure Report.
• Coordinate with client QA/validation teams on IQ/OQ/PQ protocols and audit trail requirements for migrated data.

Stakeholder & Client Management

• Act as the single point of accountability for migration workstream delivery on the client side.
• Facilitate working sessions with regulatory affairs, RA operations, IT, and compliance teams to resolve mapping conflicts and migration exceptions.
• Communicate migration progress, risks, and decisions clearly to both technical and non-technical audiences.
• Manage client expectations on data remediation effort, migration timelines, and legacy data quality realities.

Required Skills & ExperienceSkill / DomainExpectationTrackWiseDeep familiarity with TrackWise data model, document types, submission/registration objects, and export mechanismsVeeva Vault RIMFunctional understanding of Vault RIM objects, document structures, and metadata model (migration context, not configuration)Data Migration LeadershipProven track record leading large-scale data migration programmes in life sciences — project lead, not team memberData Mapping & ProfilingHands-on experience authoring source-to-target mapping specs, transformation rules, and exception handling frameworksGxP / CSV ComplianceSolid understanding of validated system migration requirements; able to own or review migration validation deliverablesStakeholder ManagementConfident in client-facing delivery; capable of managing senior regulatory and IT stakeholders through ambiguityDocumentationMeticulous; can produce and govern migration artefacts that will withstand regulatory inspectionToolsExcel / data profiling tools for mapping; JIRA or equivalent for issue tracking; SharePoint / Vault for document management
QualificationsPreferred Qualifications

• Prior experience migrating from TrackWise Digital (Sparta Systems) specifically — not just generic EDMS or QMS migrations.
• Exposure to other legacy RIM or regulatory document systems: DOCUMENTUM, OpenText, Pilgrim SmartSolve, or homegrown RA document repositories.
• Familiarity with eCTD structure and regulatory submission dossier organisation — aids mapping decisions for Submissions Archive migrations.
• Experience working alongside Veeva Professional Services or a certified Veeva SI partner on Vault RIM implementations.
• PMP, PRINCE2, or equivalent project management certification.
• Knowledge of IDMP data standards and their relevance to registration data migration.

About UsAt Zensar, we’re “experience-led everything”. We are committed to conceptualizing, designing, engineering, marketing, and managing digital solutions and experiences for over 130 leading enterprises. We are a company driven by a bold purpose: Together, we shape experiences for better futures. Whether for our clients, our people, or the world around us, this belief powers everything we do. At the heart of our culture is ONE with Client - a set of four core values that reflect who we are and how we work: One Zensar, Nurturing, Empowering, and Client Focus.
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We believe the best work happens when individuality is celebrated, growth is encouraged, and well-being is prioritized. We are an equal employment opportunity (EEO) and affirmative action employer, committed to creating an inclusive workplace. All qualified applicants will be considered without regard to race, creed, color, ancestry, religion, sex, national origin, citizenship, age, sexual orientation, gender identity, disability, marital status, family medical leave status, or protected veteran status.