SENSURA PTE. LTD. · Singapore ·
Oversee end-to-end clinical studies for a Singapore-based deep-tech health startup, managing timelines, budgets, and cross-functional teams to deliver non-invasive glucose monitoring devices while ensuring regulatory compliance.
About Sensura
Sensura is a Singapore-based deep-tech company developing next-generation health and wellness monitoring solutions, with an initial focus on non-invasive continuous glucose monitoring (CGM). Leveraging proprietary optical sensing technology, custom chip architecture, and AI-driven analytics, Sensura aims to deliver accurate, affordable, and wearable health technologies that enable continuous, painless monitoring without the need for invasive sensors.
Headquartered within the National University of Singapore ecosystem, Sensura adopts a science-driven and collaborative approach, working closely with researchers, clinicians, and industry partners to translate innovation into real-world healthcare impact.
Its platform is designed to improve long-term adherence to monitoring, support earlier detection of metabolic conditions, and expand into broader applications in preventive and personalized healthcare.
Clinical Development & Study Management
● Serve as the end-to-end accountable owner of assigned clinical studies — with full responsibility for defining, planning, and delivering within agreed project scope, scientific objectives, timeline, and budget from study conception through close-out and final reporting; own escalation and resolution of risks that could compromise delivery
● Contribute to clinical development plans and study design in collaboration with internal teams and external experts, providing input into endpoint selection, protocol design, and evidence generation strategy
● Develop and manage detailed study plans, timelines, and resource allocation; oversee study progress, identify risks proactively, and implement mitigation strategies to protect scope, quality, and on-time delivery
● Lead site identification, qualification, and selection in alignment with study scientific and operational requirements; negotiate and execute site contracts, budgets, and clinical trial agreements (CTAs) with investigators and institutions, ensuring compliance with legal, regulatory, and company standards
● Oversee performance, deliverables, and budgets of CROs, vendors, and clinical sites; lead onboarding, governance, and course-correction where required to maintain study integrity
● Take a hands-on, ground-level approach to clinical study operations — working directly alongside sites, principal investigators (PIs), internal R&D and regulatory teams, and external CRO partners to proactively troubleshoot issues, support site activation, maintain study momentum, and ensure on-time delivery of study milestones
● Ensure inspection readiness across all clinical activities (e.g., audits by regulatory authorities or notified bodies); maintain high standards of documentation and trial master file (TMF) quality, and address compliance risks proactively within a fast-moving environment
● Ensure studies are conducted incompliance with applicable regulations including EU MDR, GCP, ICH guidelines, and internal SOPs
● Ensure timely delivery of key study outputs including statistical analysis reports, clinical study reports, and regulatory documentation
Cross-Functional Leadership
● Drive alignment on study design, timelines, and deliverables across diverse internal stakeholders including R&D (hardware & software), product, regulatory, and commercial teams
● Translate clinical needs into actionable requirements for product and engineering teams, and ensure clinical insights are effectively integrated into product development cycles
● Act as the primary operational interface between internal teams, clinical sites, PIs, and external partners, maintaining clear communication channels and resolving cross-functional blockers swiftly
Team Leadership & Startup Contribution
● Mentor and guide junior team members; contribute to team capability building and onboarding of clinical operations staff
● Help establish, document, and continuously improve clinical operations processes, workflows, and SOPs suited to a fast-scaling startup
● Contribute beyond core responsibilities to support broader company priorities in a lean, startup environment
Qualifications
● MBBS, MD, or equivalent medical degree; or a Master's or PhD in Clinical Research, Epidemiology, Public Health, Life Sciences, Biomedical Sciences, Pharmacy, Nursing, or a related health sciences discipline
● 10+ years of experience in clinical research or clinical operations, preferably in medical devices, digital health, or diagnostics
● Proven track record of independently managing multi-site or global clinical studies as the accountable project lead, with full ownership of scope, timeline, and budget
● Demonstrated experience in clinical site selection, contract negotiation, and CTA execution
● Strong knowledge of clinical trial design and execution, GCP, and regulatory requirements (FDA, EU MDR)
● Experience managing CROs, clinical sites, and external vendors, with a hands-on approach to problem-solving and site support
● Excellent project management, communication, and stakeholder management skills; proficient in study management tools and systems (e.g., CTMS, eTMF, EDC)
● Ability to operate effectively in a fast-paced, ambiguous, and evolving startup environment
● Professional proficiency in both English and Mandarin (oral and written) is required
Nice to Have
● Experience with wearables, non-invasive monitoring, or CGM technologies
● Familiarity with Software as a Medical Device (SaMD) development and associated regulatory pathways
● Experience supporting regulatory submissions (e.g., CE marking under EU MDR, FDA 510(k) or De Novo clearance)
● Exposure to decentralized clinical trial (DCT) methodologies or remote patient monitoring