9 дней назад
Senior Clinical Research Clinician
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Clinical Research Clinician (Clinical Trials): Leading the design, conduct, interpretation, and reporting of clinical studies in Shanghai with an accent on protocol development, patient safety, data integrity, and site performance. Focus on overseeing study teams, managing clinical and regulatory risks, interpreting efficacy and safety data, and maintaining investigator and site relationships.
Location: Shanghai, China
Company
develops and supports medicines through clinical research, regulatory activities, and collaboration with investigators and healthcare stakeholders.
What you will do
- Co-chair clinical study teams and provide accountability for study design, conduct, interpretation, reporting, timelines, and quality.
- Develop clinical trial strategies, outlines, protocols, amendments, monitoring guidance, informed consent materials, and training content.
- Identify clinical, safety, data integrity, recruitment, and Good Clinical Practice risks and implement mitigation plans.
- Review and interpret efficacy and safety data, oversee safety reviews, manage protocol deviations, and contribute to clinical study reports and publications.
- Select and oversee countries, sites, investigators, CROs, and vendors while supporting recruitment and study delivery.
- Act as the clinical site liaison by maintaining investigator relationships, coaching site staff, monitoring performance, and resolving operational or protocol issues.
Requirements
- Medical, scientific, veterinary, or pharmacy qualification required, such as an M.D., Ph.D., D.V.M., M.S., PharmD, or equivalent.
- Experience conducting and executing clinical trials, including feasibility, recruitment, investigator performance, and site relations.
- Knowledge and experience in Good Clinical Practice and clinical trial execution.
- Ability to translate innovative approaches into actions focused on trial execution and site performance.
- Knowledge of local and international clinical trial regulations and experience with clinical study strategy, oversight, and interpretation are preferred.
- Postgraduate medical or drug development training, scientific publications, and leadership or management experience are preferred.
Culture & Benefits
- Collaborate with clinical, statistical, pharmacology, outcomes research, regulatory, commercial, and site management functions.
- Work with investigators, key opinion leaders, advisory boards, regulators, and clinical sites.
- Coach and mentor less experienced clinicians and contribute to clinical staff training.
- Participate in continuous improvement, best-practice sharing, expert panels, publications, and regulatory submissions.
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