Ophthalmic AI Clinical Trials Lead (Senior CRA)

MEDIWHALE (APAC) PTE. LTD.; Singapore; In loco; SGD 70.000 - 100.000; Tempo pieno

Descrizione del lavoro

Mediwhale in Singapore is seeking a Clinical Research Associate (CRA) or Senior CRA to run global clinical studies on-site from start-up to close-out, owning TMF and supporting CRO oversight for pivotal studies.

You will conduct AV and feasibility studies, draft protocols, manage site start-up, monitor recruitment, and ensure regulatory readiness. Willingness to travel for 6–8 weeks per study is required.

Competenze

• Degree in Life Sciences, Biomedical Engineering, Nursing, Optometry, Public Health or a related field.
• Hands-on clinical research experience: 3+ years (CRA) or 5+ years including independent site monitoring (Senior CRA).
• Willingness to travel for on-site studies in Southeast Asia and the US.

Mansioni

• Draft and amend study protocols, CINs, synopses and informed consent forms with the HCO and biostatistics team.
• Site start-up, contracting, recruitment tracking, and monitoring of study progress; ensure protocol compliance.
• On-site study execution for AV and feasibility studies, including training camera operators and data-quality checks.
• Coordinate interim analyses with statisticians and provide data for AV reports and regulatory responses.
• Own the TMF for in-house studies; manage deviations and CAPAs, SOPs and documentation.
• Support CRO oversight, budgeting, timelines and regulatory submissions.

Conoscenze

Fluent English

Formazione

Degree in Life Sciences or related field

Descrizione del lavoro

Mediwhale in Singapore is seeking a Clinical Research Associate (CRA) or Senior CRA to run global clinical studies on-site from start-up to close-out, owning TMF and supporting CRO oversight for pivotal studies.

You will conduct AV and feasibility studies, draft protocols, manage site start-up, monitor recruitment, and ensure regulatory readiness. Willingness to travel for 6–8 weeks per study is required.