Kivo · 3 months ago
Implementation Manager (Life Sciences SaaS)
United States
Full-time
Remote
Senior Level
5+ years expKivo is a company focused on providing innovative solutions for the life sciences sector. They are seeking an Implementation Manager to oversee end-to-end implementations of their platform for biopharma and med-device customers, ensuring projects are delivered on time and meet regulatory standards.
Document ManagementDocument PreparationLife ScienceSaaS
Responsibilities
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)
Qualification
Required
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
Preferred
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
Company
Kivo
Kivo provides document management and submission orchestration for life science companies.
11-50 employees
Funding
Current Stage
Early StageTotal Funding
$11.25M2025-12-23Series Unknown· $5.13M
2024-01-30Debt Financing· $3.13M
2022-03-22Seed· $3M
Leadership Team
Toban Zolman
Chief Executive Officer
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