Kivo Inc.
Implementation Manager (Life Sciences SaaS)
Kivo Inc., Portland, Oregon, United States, 97204
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
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