Implementation Manager; Life Sciences SaaS

Implementation Manager (Life Sciences SaaS)

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Location: Portland, OR or Remote (U.S. required)

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Function: Professional Services

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Reports to: Head of Services

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.

• 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).

• 5–8+ years delivering enterprise software implementations for life‑sciences (e.g., eQMS, eTMF, RIM, CTMS, EDMS); vendor or consulting background (Veeva, Master Control, 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.

• Experience with platforms like Vault (Quality/RIM/Clinical),
  Master Control
  , Track Wise/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.

• 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