Solution Implementation Lead (Connected Devices)

Solution Implementation Lead

The Solution Implementation Lead is the end-to-end execution owner and subject-matter expert for the development, validation, and operationalization of new connected medical device and digital health solutions.

This role partners closely with the Strategic Solutions Lead to evaluate, shape, and deliver new solution offerings aligned to the strategic priorities of the Connected Devices business, with a primary focus on the respiratory service line. The role bridges strategy, execution, validation, and operational readiness, ensuring solutions progress from concept through Business Go-Live and are ready for scalable study deployment.

Key Responsibilities and Oversight

Experience Supporting Respiratory Clinical Trials

Experience supporting respiratory clinical trials (e.g., asthma, COPD, pulmonary indications) is required. Candidates without direct respiratory trial experience clearly demonstrated within their resume will not be considered.

Solution Evaluation & Strategy Support

• Partner with Strategic Solutions Leads (SSL) to evaluate new digital health and medical device solutions aligned to Connected Devices strategy.
• Provide SME input into solution feasibility, operational workflows, regulatory considerations, and validation approach.
• Support Strategic Solutions as needed with business case development, budget inputs, go-to-market strategy and customer-facing SME in customer presentations.

End-to-End Solution Startup Execution Ownership

• Own end-to-end execution of approved solutions from business case approval through Business Go-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.
• Confirm readiness at each startup stage and before Business Go-Live.

Cross-Functional Orchestration & Technical Leadership

• Lead and coordinate execution across Engineering, IT, Validation, QA, Regulatory, Data Management, Operations, Logistics, Vendors, Field Support and Training.
• Translate high-level solution 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.
• Provide expert troubleshooting guidance to operations and support teams; engage with sites and customers as needed to resolve complex issues.

Solution-Level Readiness, Quality & Compliance

• Ensure solution-level readiness, including documentation, validation completion, training delivery, support models, and escalation pathways.
• Partner closely with Solution Specialists to ensure regulatory and compliance requirements are met without late-stage disruption.
• Lead quality management, process improvement, and continuous improvement initiatives.
• Contribute to internal SOPs, study templates, and site/patient-facing materials as a solution SME.

Governance, Escalation & Stakeholder Management Oversight

• Own resolution of startup-level issues; escalate appropriately when:
• Scope or solution intent is impacted (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 Business Go-Live to study execution leadership (e.g., CD Project Manager) and retain an escalation/support role for solution-level issues post-handoff.

Required Knowledge, Skills & Abilities

• 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, and executive-level presentation skills.
• Proven ability to establish and maintain effective working relationships with internal teams, vendors, sponsors, sites, and clients.
• Occasional travel may be required.

Minimum Education & Experience

• 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, and cross-functional initiatives.
• Strong business acumen with experience supporting solution development, commercialization, and delivery.