Hybrid Clinical Safety Lead – Digital Health Solutions

Position: Clinical Safety Officer

Location: Hybrid role split between working remotely and onsite in Central London.

Duration: 12 month initial contract.

IR35 status: Inside.

Role Description

The Clinical Safety Officer (CSO) for the Digital Screening programme provides end-to-end clinical safety assurance across the product lifecycle, ensuring digital solutions comply with mandatory clinical safety standards (DCB0129 and DCB0160) and NHSE governance. The CSO leads clinical risk identification and hazard analysis, determines Safety Assurance Levels (SAL), advises on clinical design to mitigate patient-safety risks, produces and reviews Clinical Safety Case Reports and hazard logs, assesses and supports incident investigations and post-implementation risk reviews, attends and presents to Clinical Safety Group (CSG) and programme governance, and embeds clinical safety into agile and User-Centered Design delivery practices.

The role requires documenting risks and assurance activities in programme tooling (e.g. Aspyre) and driving improvements in workflows and tooling to enable safe, more frequent releases. This is a highly collaborative role requiring strong stakeholder management across clinical, technical, and senior leadership groups. The CSO must act as a trusted advisor and enabler, working proactively and positively to facilitate progress when clinical safety challenges arise, rather than acting as a blocker. Success depends on building strong relationships, communicating complex clinical risks clearly to diverse audiences, and maintaining an enthusiastic, solution-focused attitude that helps multidisciplinary teams navigate safety requirements whilst maintaining delivery momentum.

The role must be filled by a clinically registered professional with specialist clinical safety training and hands-on experience in digital delivery. Without effective and timely Clinical Risk Management delivered through this role, digital solutions within Digital Screening cannot be successfully delivered and used.

Key Skills and Experience

• Clinical credentials and certification: Clinically/medically qualified and currently registered with relevant UK regulatory body (e.g., GMC, NMC, HCPC), plus recognized Clinical Safety Officer training and evidence of CPD in clinical safety.
• Deep practical knowledge of clinical safety standards and governance: Demonstrable experience applying DCB0129 and DCB0160, developing Clinical Safety Cases, managing Hazard Logs, determining SALs, and working within NHSE Clinical Safety Management System and governance structures.
• Hands-on digital delivery experience: Several years delivering digital health solutions in complex NHS or equivalent environments; strong understanding of agile delivery, User-Centered Design, DevOps/continuous delivery practices, and proven ability to balance release velocity with safety rigor.
• Risk management and incident response: Expert facilitation of hazard workshops and collaborative risk assessment sessions; quantitative and qualitative risk assessment skills; experience documenting and tracking risks (e.g. in Aspyre); proven ability to assess incidents for clinical risk, advise investigations, and guide remediation.
• Technical appreciation: Familiarity with digital health system architectures, interoperability issues, regulatory contexts (medical device regulations, ISO 14971, IEC 62304 where relevant), ability to translate clinical risks into technical requirements, and awareness of emerging technology risks (e.g., AI/ML).
• Exceptional stakeholder management and communication: Proven ability to build and maintain strong relationships with diverse stakeholders across clinical, technical, product, delivery, and senior leadership groups; excellence in communicating complex clinical safety concepts clearly to both clinical and non-clinical audiences; experience managing upward to governance boards; strong written communication for safety documentation and presentations; ability to influence and negotiate with tact and diplomacy.
• Collaboration and teamwork: Strong collaborative mindset with proven ability to work effectively across multidisciplinary teams; experience embedding clinical safety thinking across agile teams rather than operating in isolation; ability to coach Clinical Safety Coordinators and build capability in others; track record of fostering a "one team" mentality; active listening skills and openness to diverse perspectives.
• Proactive, positive and solution-focused attitude: Demonstrates a proactive, enthusiastic, and positive approach to clinical safety challenges; acts as an enabler and facilitator rather than a blocker, helping teams find pragmatic solutions that balance safety with delivery pace; solution-oriented mindset; ability to anticipate issues early and take ownership of resolving them; resilience and adaptability in complex or high-pressure situations; maintains composure and constructive approach when facing resistance or competing priorities.
• Problem-solving and continuous improvement: Analytical thinking and systematic problem-solving abilities; track record of improving clinical safety workflows, governance processes, and tooling adoption to support faster, safer releases; process improvement mindset; comfortable with ambiguity and capable of working pragmatically within evolving frameworks.
• Leadership and professional influence: Ability to provide professional leadership in clinical safety across the programme; credibility to challenge and influence product, technical, and delivery decisions when patient safety is at risk; comfortable speaking up and raising concerns constructively whilst maintaining positive working relationships; role-modeling of professional standards and clinical safety best practice.