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43 минуты назад

Clinical Trial Manager (Mandarin)

Формат работы
remote (только Australia)
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
Australia
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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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

hirify.global 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.

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