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
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