Clinical Research Associate / Senior Clinical Research Associate

Mediwhale develops Software as a Medical Device (SaMD). We build AI tools that use retinal images to detect disease risk, under our Dr. Noon platform for diabetic retinopathy, cardiovascular disease and chronic kidney disease. Our Clinical Operations team in Singapore runs global clinical studies that support international regulatory submissions, including to the US Food and Drug Administration (FDA).

We're looking for a Clinical Research Associate (CRA) or Senior CRA to run our global clinical studies on the ground, from site start-up to close-out. You'll work on in-house analytical validation (AV) and feasibility studies in Southeast Asia and the US, own the Trial Master File (TMF) for those studies, and co-monitor sites in a US pivotal study run by a contract research organisation (CRO). You'll report to the Head of Clinical Operations (HCO). You'll be based in Singapore.

We'll set the level at offer, based on your experience. At CRA level you'll support the HCO on protocol drafting and study decisions. At Senior CRA level you'll lead them and act as on-site lead.

This is a growth role. As the team expands, the path leads to more senior role, where you'd lead global studies from planning to close-out and own CRO oversight for pivotal studies.

Key responsibilities

• Study documentation. Draft and amend study protocols (Clinical Investigation Plans, CIPs), synopses and informed consent forms with the HCO and the biostatistics team. Prepare submissions to institutional review boards (IRBs) and ethics committees in the US and Southeast Asia, and answer their queries. Draft monitoring and data-management plans.
• Site start-up and study management. Help select and contract sites, and manage start-up documents and site invoices. Track recruitment, support site-level recruiting and report progress to sites and internal teams. Check protocol compliance and manage deviations.
• On-site study execution. Work on site for 2 AV studies and 1 to 2 feasibility studies a year that support our FDA submissions, each lasting 6 to 8 weeks. This covers site set-up, operator training, enrolment, daily data-quality checks, deviation management and close-out. You'll direct camera operators on site.
• Analytical validation studies. Manage enrolment of targeted cohorts (for example, high-risk participants) against the enrolment plan. Apply the protocol's study hold and restart rules, and act on the HCO's decisions. Coordinate interim analyses with internal and external statisticians, and supply data for AV reports and regulatory responses.
• CRO-led pivotal study. Co-monitor sites, review CRO reports and key performance indicators (KPIs), and escalate enrolment, timeline and quality issues to the HCO. Support CRO selection and the sponsor TMF.
• TMF and compliance. Own the TMF for in-house studies and keep it filed, quality-checked and inspection-ready. Manage protocol deviations and corrective and preventive actions (CAPAs), follow department standard operating procedures (SOPs) and templates, and supervise the documentation intern's TMF work.
• Cross-functional work. Give input on study timelines and budgets, report progress weekly, provide study data and documents for regulatory submissions, and back up basic analyses run from scripts supplied by biostatistics (R or Python). Coding skill is not mandatory, and we'll train you to run them.

Requirements

• Degree in Life Sciences, Biomedical Engineering, Nursing, Optometry, Public Health or a related field
• At least 3 years in clinical research as a CRA, study coordinator or in clinical operations, or as a practising optometrist with an interest in clinical research (CRA level); at least 5 years, including independent site monitoring (Senior CRA level)
• Hands-on, and willing to take charge of a study on site and to learn and operate retinal photography for in-house studies (full training provided)
• Site monitoring experience, ideally in more than one country (US or Southeast Asia)
• Able to travel for on-site studies of 6 to 8 weeks in Southeast Asia and the US
• Fluent in English

Preferred

• International Council for Harmonisation (ICH) Good Clinical Practice (GCP) E6(R3) and ISO 14155 training certification
• Working knowledge of FDA requirements for device studies (21 CFR 50, 56 and 812) and the TMF Reference Model
• Medical device, diagnostics or SaMD studies
• Ophthalmic imaging background, fundus camera operation
• Field studies in emerging markets
• Experience with CRO-led studies or co-monitoring
• Basic R or Python for running analysis scripts (training provided)
• Optometrists interested in breakthrough ophthalmic AI development are welcome to apply