Kivo

Manage end-to-end implementations of a life sciences SaaS platform including project planning, validation, integrations, training, and post-go-live support ensuring audit readiness and stakeholder satisfaction. | 5-8+ years of enterprise software implementation experience in life sciences with strong project leadership, validation expertise in regulated environments, data migration skills, and familiarity with SaaS quality/regulatory systems. | Implementation Manager (Life Sciences SaaS) • Location: Portland, OR or Remote (U.S. required) • Function: Professional Services • Reports to: Head of Services Role summary Own end-to-end implementations of the Kivo platform for biopharma and med-device customers. You'll run projects from scoping through go-live and support, coordinating closely with Customer Success, Data Migration, Technical Support, and Product to deliver validated, audit-ready outcomes on time and within scope. Responsibilities span solution design/configuration, integrations, training, and post-go-live stabilization—consistent with life-sciences best practices. What you'll do • Plan & deliver multiple implementations concurrently: project charter and plan, timelines, RAID, status, risk/issue escalation, stakeholder comms, and executive readouts. • Facilitate discovery & design workshops; translate regulated process requirements into configured solutions and documented decisions. • Own validation workstream with a risk-based approach: author/review plans, requirements, test protocols, traceability, deviations, and final reports aligned to 21 CFR Part 11 / Annex 11 expectations. • Drive change management: defect triage, go-live readiness, training enablement, and post-go-live support. • Partner cross-functionally with Sales to deliver value, with CS for success plans, with Support on SLAs/hand-off, and with Product for backlog/feedback • Own scope & quality: SOW adherence, acceptance criteria, and measurable outcomes (time-to-value, CSAT, on-time delivery). What you've done • 5–8+ years delivering enterprise software implementations for life-sciences (e.g., eQMS, eTMF, RIM, CTMS, EDMS); vendor or consulting background (Veeva, MasterControl, IQVIA, or similar). • Demonstrated ownership of validation in regulated environments (GxP; 21 CFR Part 11 / Annex 11) and creation of CSV/CSA deliverables. • Hands-on with data migrations and integrations (APIs/iPaaS), plus configuration of SaaS quality/regulatory systems. • Strong project leadership: multi-workstream delivery, stakeholder management, crisp status/risk comms; PMP a plus. Excellent facilitation and documentation skills; comfortable “rolling up sleeves” on design, testing, and cutover. • Nice to have • Experience with platforms like Vault (Quality/RIM/Clinical), MasterControl, TrackWise/ETQ, or related. • Familiarity with eClinical and regulatory content processes (submission/registration, TMF, deviations/CAPA, training). PSA/Jira/Confluence proficiency; prior consulting or SI experience. How we'll measure success • On-time/on-scope go-lives and reduced time-to-value • Validation/audit readiness at go-live • CSAT/NPS, low escalation rate, clean hand-off to CS/Support • Data migration quality (reconciliation/defects) and adoption KPIs

Manage end-to-end SaaS platform implementations for life sciences customers, ensuring validated, audit-ready outcomes through project planning, stakeholder communication, validation, training, and post-go-live support. | Experience delivering enterprise software implementations in life sciences regulated environments with strong project leadership, validation expertise (21 CFR Part 11 / Annex 11), data migration skills, and SaaS configuration knowledge. | Implementation Manager (Life Sciences SaaS) Location: Portland, OR or Remote (U.S. required) Function: Professional Services Reports to: Head of Services Role summary Own end-to-end implementations of the Kivo platform for biopharma and med-device customers. You'll run projects from scoping through go-live and support, coordinating closely with Customer Success, Data Migration, Technical Support, and Product to deliver validated, audit-ready outcomes on time and within scope. Responsibilities span solution design/configuration, integrations, training, and post-go-live stabilizationconsistent with life-sciences best practices. What you'll do • Plan & deliver multiple implementations concurrently: project charter and plan, timelines, RAID, status, risk/issue escalation, stakeholder comms, and executive readouts. • Facilitate discovery & design workshops; translate regulated process requirements into configured solutions and documented decisions. • Own validation workstream with a risk-based approach: author/review plans, requirements, test protocols, traceability, deviations, and final reports aligned to 21 CFR Part 11 / Annex 11 expectations. • Drive change management: defect triage, go-live readiness, training enablement, and post-go-live support. • Partner cross-functionally with Sales to deliver value, with CS for success plans, with Support on SLAs/hand-off, and with Product for backlog/feedback • Own scope & quality: SOW adherence, acceptance criteria, and measurable outcomes (time-to-value, CSAT, on-time delivery). What you've done • 58+ years delivering enterprise software implementations for life-sciences (e.g., eQMS, eTMF, RIM, CTMS, EDMS); vendor or consulting background (Veeva, MasterControl, IQVIA, or similar). • Demonstrated ownership of validation in regulated environments (GxP; 21 CFR Part 11 / Annex 11) and creation of CSV/CSA deliverables. • Hands-on with data migrations and integrations (APIs/iPaaS), plus configuration of SaaS quality/regulatory systems. • Strong project leadership: multi-workstream delivery, stakeholder management, crisp status/risk comms; PMP a plus. • Excellent facilitation and documentation skills; comfortable rolling up sleeves on design, testing, and cutover. Nice to have • Experience with platforms like Vault (Quality/RIM/Clinical), MasterControl, TrackWise/ETQ, or related. • Familiarity with eClinical and regulatory content processes (submission/registration, TMF, deviations/CAPA, training). • PSA/Jira/Confluence proficiency; prior consulting or SI experience. How we'll measure success • On-time/on-scope go-lives and reduced time-to-value • Validation/audit readiness at go-live • CSAT/NPS, low escalation rate, clean hand-off to CS/Support • Data migration quality (reconciliation/defects) and adoption KPIs

Lead end-to-end implementations of the Kivo platform for life sciences customers, managing project plans, validation, integrations, training, and cross-functional collaboration to ensure audit-ready, on-time delivery. | 5-8+ years in enterprise software implementations for life sciences with strong validation experience under 21 CFR Part 11/Annex 11, hands-on data migration and SaaS configuration skills, and excellent project leadership. | Implementation Manager (Life Sciences SaaS) • Location: Portland, OR or Remote (U.S. required) • Function: Professional Services • Reports to: Head of Services Role summary Own end-to-end implementations of the Kivo platform for biopharma and med-device customers. You’ll run projects from scoping through go-live and support, coordinating closely with Customer Success, Data Migration, Technical Support, and Product to deliver validated, audit-ready outcomes on time and within scope. Responsibilities span solution design/configuration, integrations, training, and post-go-live stabilization—consistent with life-sciences best practices. What you’ll do Plan & deliver multiple implementations concurrently: project charter and plan, timelines, RAID, status, risk/issue escalation, stakeholder comms, and executive readouts. Facilitate discovery & design workshops; translate regulated process requirements into configured solutions and documented decisions. Own validation workstream with a risk-based approach: author/review plans, requirements, test protocols, traceability, deviations, and final reports aligned to 21 CFR Part 11 / Annex 11 expectations. Drive change management: defect triage, go-live readiness, training enablement, and post-go-live support. Partner cross-functionally with Sales to deliver value, with CS for success plans, with Support on SLAs/hand-off, and with Product for backlog/feedback Own scope & quality: SOW adherence, acceptance criteria, and measurable outcomes (time-to-value, CSAT, on-time delivery). What you’ve done 5–8+ years delivering enterprise software implementations for life-sciences (e.g., eQMS, eTMF, RIM, CTMS, EDMS); vendor or consulting background (Veeva, MasterControl, IQVIA, or similar). Demonstrated ownership of validation in regulated environments (GxP; 21 CFR Part 11 / Annex 11) and creation of CSV/CSA deliverables. Hands-on with data migrations and integrations (APIs/iPaaS), plus configuration of SaaS quality/regulatory systems. Strong project leadership: multi-workstream delivery, stakeholder management, crisp status/risk comms; PMP a plus. Excellent facilitation and documentation skills; comfortable “rolling up sleeves” on design, testing, and cutover. Nice to have Experience with platforms like Vault (Quality/RIM/Clinical), MasterControl, TrackWise/ETQ, or related. Familiarity with eClinical and regulatory content processes (submission/registration, TMF, deviations/CAPA, training). PSA/Jira/Confluence proficiency; prior consulting or SI experience. How we’ll measure success On-time/on-scope go-lives and reduced time-to-value Validation/audit readiness at go-live CSAT/NPS, low escalation rate, clean hand-off to CS/Support Data migration quality (reconciliation/defects) and adoption KPIs