8 дней назад
Associate, Study Management II/CTM II (Clinical Research)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Associate, Study Management II/CTM II (Clinical Research): Executing clinical study activities and supporting cross-functional study teams, study documents, training, and external vendors with an accent on ICH/GCP compliance, clinical trial systems, and stakeholder coordination. Focus on maintaining study status in CTMS, resolving study issues, overseeing vendors, and supporting protocol, eCRF, IRT, and CSR development.
Location: Shanghai, China
Company
develops medicines and solutions across immunology, oncology, neuroscience, and aesthetics.
What you will do
- Execute assigned elements of clinical studies in compliance with ICH/GCP, global regulations, and internal procedures.
- Support the Study Project Manager and cross-functional study team, including meeting preparation, minutes, stakeholder updates, and CTMS maintenance.
- Support development of study protocols, blueprints, informed consent forms, eCRFs, IRT, CSRs, and related systems and documents.
- Support vendor selection, scope development, management, and oversight.
- Generate training for study teams, sites, and vendors.
- Identify, resolve, and escalate study issues and participate in process improvement initiatives.
Requirements
- Bachelor’s degree or equivalent, typically in nursing or a scientific field.
- Registered Nurse licensure with an Associate Degree in Nursing and relevant experience may also be accepted.
- Two years of pharmaceutical or clinical research experience, or a professional equivalent, is desired.
- Strong analytical and critical-thinking skills.
- Good communication skills.
Culture & Benefits
- Work in a clinical research environment focused on innovative medicines and serious health conditions.
- Operate under established quality, regulatory, and compliance standards.
- Participate in cross-functional collaboration and process improvement.
- is committed to integrity, innovation, and equal employment opportunity.
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