8 дней назад
Clinician, Senior Manager
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Clinician, Senior Manager (Clinical Development): Designing, executing, monitoring, and interpreting clinical trials in China with an accent on medical oversight, participant safety, protocol quality, and regulatory compliance. Focus on reviewing safety data, supporting risk management and monitoring committees, interpreting clinical results, and coordinating investigators and cross-functional study teams.
Location: Beijing, China; hybrid work arrangement
Company
develops and delivers medicines through research-driven clinical development programs.
What you will do
- Contribute to protocol design, authoring, amendments, and optimization for clinical studies.
- Provide medical oversight throughout clinical trial execution and ensure compliance with internal standards, ICH-GCP, and applicable regulations.
- Review clinical data, adverse events, safety signals, protocol deviations, and patient-level information.
- Support safety review plans, risk management activities, Data Monitoring Committees, and Endpoint Adjudication Committees.
- Provide clinical input into statistical analysis plans, tables/listings/figures, clinical study reports, and regulatory documentation.
- Act as the primary medical and scientific contact for investigators and collaborate with global study teams and internal stakeholders.
Requirements
- MD or equivalent medical degree, with clinical practice and/or drug development experience; or a bachelor's degree or equivalent with 4+ years of biopharmaceutical clinical research and development experience.
- Strong knowledge of clinical development, safety monitoring, regulatory requirements, and ICH-GCP.
- Expertise in clinical development and lifecycle strategy, with strong disease-area knowledge and scientific credibility.
- Ability to address scientific, clinical, regulatory, and commercial considerations.
- Strong project management, communication, accountability, and stakeholder-management skills.
- Ability to work collaboratively and adapt to complex and changing development environments.
Culture & Benefits
- Hybrid work arrangement in Beijing.
- Cross-functional collaboration with global study teams.
- Equal employment opportunity in accordance with applicable legislation.
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