Implementation Manager, Life Sciences SaaS

Job not on LinkedIn

September 18

🌲 Oregon – Remote

Although this job is listed in Oregon, this company may be open to hiring remote in other states.

⏰ Full Time

🟡 Mid-level

🟠 Senior

🛠️ Implementation Specialist

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Kivo

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Healthcare Insurance • Pharmaceuticals • Biotechnology

Kivo is a compliant document, content, and process management platform specifically tailored to the life science industry. It offers solutions for Document Management (DMS), electronic Trial Master File (eTMF), Regulatory Information Management (RIM), and Quality Management (QMS). Designed for pharmaceutical and medical device companies, Kivo helps streamline workflows, ensure compliance, and manage documentation throughout its lifecycle, all while providing affordability and user-friendly operations.

11 - 50 employees

Founded 2021

⚕️ Healthcare Insurance

💊 Pharmaceuticals

🧬 Biotechnology

💰 $3M Seed Round on 2022-04

📋 Description

• Own end-to-end implementations of the Kivo platform for biopharma and med-device customers • Plan & deliver multiple implementations concurrently: project charter and plan, timelines, RAID, status, risk/issue escalation, stakeholder communications, 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 • Drive change management: defect triage, go-live readiness, training enablement, and post-go-live support • Partner cross-functionally with Sales, Customer Success, Support, and Product to deliver value and ensure smooth hand-offs • Own scope & quality: SOW adherence, acceptance criteria, and measurable outcomes (time-to-value, CSAT, on-time delivery) • Oversee data migrations and integrations, training, and post-go-live stabilization consistent with life-sciences best practices

🎯 Requirements

• 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 experience with data migrations and integrations (APIs/iPaaS) • Configuration experience of SaaS quality/regulatory systems • Strong project leadership: multi-workstream delivery, stakeholder management, status/risk communications; PMP a plus • Excellent facilitation and documentation skills; comfortable performing design, testing, and cutover tasks • Experience with Vault, MasterControl, TrackWise/ETQ or related platforms (nice to have) • Familiarity with eClinical and regulatory content processes (submission/registration, TMF, deviations/CAPA, training) (nice to have) • PSA/Jira/Confluence proficiency; prior consulting or SI experience (nice to have) • Located in the United States; Portland, OR location or remote (U.S. required) • Reports to Head of Services