5 дней назад
TMF Specialist (Clinical Research)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
TMF Specialist (Clinical Research): Managing trial master file records and records-management systems in a clinical research environment with an accent on filing accuracy, regulatory compliance, and project timelines. Focus on coordinating record retrieval and disposition, maintaining secure storage, training staff, and ensuring compliance with ICH, GCP, and applicable regulations.
Location: Dalian, Liaoning, China
Company
provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.
What you will do
- Perform complex administrative tasks and maintain project data within established timelines and project plans.
- Coordinate record retrieval, study closeout, transfers, recalls, and disposition activities.
- Manage scanning processes, train staff, and oversee records-management tasks and procedures.
- Monitor filing accuracy, compliance with file plans and SOPs, records-center security, and storage operations.
- Serve as a primary contact for internal and external clients and maintain effective communications.
- Design and administer records-management systems and processes while monitoring project outputs and deadlines.
Requirements
- High school diploma or equivalent.
- 3–4 years of experience in a relevant clinical research environment, or an equivalent combination of education, training, and experience.
- Knowledge of ICH, GCP, and applicable local clinical research laws, regulations, and guidelines.
- Extensive knowledge of records-management laws and regulations, technology applications, computer software, and accurate data entry.
- Strong attention to detail, organization, planning, problem-solving, decision-making, time management, and prioritization skills.
- Good command of English and the ability to communicate effectively with internal and external clients.
Culture & Benefits
- Full-time employment.
- May require shift work.
- Role involves prolonged sitting, repetitive writing and keyboarding, standing, walking, reaching, and handling paper files.
- May require stooping, kneeling, ladder use, and unaided lifting of objects up to 40 pounds/18 kilograms.
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