43 минуты назад
Clinical Trial Manager (Mandarin)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Clinical Trial Manager (Mandarin) (Clinical Research/Oncology and Rare Disease): Leading the planning, conduct, and oversight of clinical studies in Australia with an accent on clinical monitoring, site management, regulatory submissions, and data quality. Focus on developing recruitment strategies, managing study risks and vendors, ensuring ICH-GCP compliance, and coordinating CRAs, investigators, and cross-functional teams.
Location: Remote, Australia
Company
is a contract research organization integrating clinical trial execution with scientific expertise, laboratory services, and advanced data sciences, with a focus on oncology and rare disease.
What you will do
- Lead the operational planning, conduct, and oversight of clinical studies in accordance with protocols, SOPs, ICH-GCP, and regulatory requirements.
- Act as the primary clinical contact for clients and coordinate CRAs, CTAs, investigators, vendors, regulatory teams, data management, QA, and project management.
- Develop clinical documents, monitoring strategies, training materials, recruitment and retention strategies, and study trackers.
- Drive site feasibility, start-up, enrollment, maintenance, close-out, submissions, approvals, and investigational product accountability.
- Monitor study metrics, data quality, compliance, risks, CAPA plans, eTMF implementation, and audit readiness.
- Support investigator meetings, site contracts and budgets, vendor management, business development, and project management activities as needed.
Requirements
- Bachelor’s degree or equivalent experience in a science or health-related field; an advanced degree is preferred.
- 5–8 years of clinical research experience or demonstrated equivalent competencies, including significant clinical monitoring experience.
- Experience with Phase 1, first-in-human, and healthy volunteer clinical trials.
- Mandarin proficiency is required to support Mandarin-speaking clients.
- Experience with Microsoft Office products and strong communication, organization, attention to detail, and interpersonal skills.
- Ability to travel domestically and internationally, including overnight stays.
Culture & Benefits
- Remote work arrangement based in Australia.
- Work across clinical operations, scientific, laboratory, data science, and regulatory functions.
- Exposure to oncology and rare disease clinical studies.
- Opportunity to collaborate with international clients, investigators, vendors, and study teams.
Будьте осторожны: если работодатель просит войти в их систему, используя iCloud/Google, прислать код/пароль, запустить код/ПО, не делайте этого - это мошенники. Обязательно жмите "Пожаловаться" или пишите в поддержку. Подробнее в гайде →
Похожие вакансии
3 дня назад
Senior Clinical Lead
6 дней назад
Senior Clinical Research Associate (Clinical Monitoring)
1 день назад
Senior Clinical Line Manager
6 дней назад
Senior Clinical Trial Lead (Clinical Research)
4 дня назад
Oversight Director, Clinical Operations (Biotech)
232 000 - 283 000$
2 дня назад
In-House Clinical Research Associate (Contract) (Gene Therapy)
60 - 70$