Solution Implementation Lead (Connected Devices)
- Partner with Strategic Solutions Leads(SSL)to evaluate new digital health and medical device solutions alignedtoConnected Devices strategy.
- Provide SME input into solution feasibility, operational workflows, regulatory considerations, and validation approach.
- Support Strategic Solutions as needed withbusiness case development, budgetinputs,go-to-marketstrategyandcustomer-facingSME incustomer presentations.
- Ownend‑to‑endexecution of approved solutions from business case approval through BusinessGo‑Live, serving as the single point of accountability for startup outcomes.
- Develop and manage the startup plan, including milestones, dependencies, risks, constraints, and mitigation strategies.
- Ensure solution design, operational workflows, and validation activities are aligned with study, program, and stakeholder needs.
- Confirmreadinessat eachstartupstageandbeforeBusiness Go‑Live.
- Lead and coordinate execution across Engineering, IT,Validation,QA, Regulatory, Data Management, Operations, Logistics, Vendors,Field Supportand Training.
- Translatehigh‑levelsolution concepts into clear device, system, service, and validation requirements understood by technical and validation teams.
- Support vendor relationships, including issue resolution, design alignment, and budget collaboration.
- Provideexpert troubleshooting guidance to operations and support teams; engage with sites and customers as needed to resolve complex issues.
- Ensuresolution‑levelreadiness, including documentation, validation completion, training delivery, support models, and escalation pathways.
- Partner closely withSolution Specialiststo ensure regulatory and compliance requirements are met withoutlate‑stagedisruption.
- Leadquality management, process improvement, and continuous improvement initiatives.
- Contribute to internal SOPs, study templates, and site/patient‑facingmaterials as a solution SME.
- Own resolution ofstartup‑levelissues; escalate appropriately when:
- Scope or solution intent isimpacted(to Strategic Solutions Lead)
- Timeline, investment, or delivery risk requires acceptance (to Governance / Sponsor)
- Provide clear, consistent communications to internal stakeholders, sponsors, and leadership on startup status, risks, and readiness.
- Transfer ownership at BusinessGo‑Liveto study execution leadership (e.g., CD Project Manager) andretainan escalation/support role forsolution‑levelissuespost‑handoff.
- Strong knowledge of digital health, connected medical devices, and regulated clinical environments.
- Working knowledge of FDA guidelines and global regulatory expectations and their operational impact.
- Advanced project and program management skills in complex, matrixed organizations.
- Excellent technical aptitude related to systems, platforms, integrations, and device workflows.
- Strong communication, stakeholder management, andexecutive‑levelpresentation skills.
- Proven ability toestablishand maintain effective working relationships with internal teams, vendors, sponsors, sites, and clients.
- Occasional travel may berequired.
- Bachelor’s degree or equivalent combination of education, training, and experience.
- 10+ years of relevant experience in healthcare, pharmaceutical, life sciences, or digital health environments.
- Demonstrated leadership experience managing people, operations, andcross‑functionalinitiatives.
- Strong business acumen with experience supporting solution development, commercialization, and delivery.
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