2 дня назад
Senior Trial Manager
150 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Trial Manager (Clinical Trial Operations): Overseeing the planning, execution, and completion of clinical trials for biotech, medtech, and specialty pharma clients with an accent on regulatory compliance, site activation, vendor management, and monitoring quality. Focus on coordinating global trial operations teams, maintaining clinical monitoring plans, reviewing study documentation and monitoring reports, and resolving quality issues.
Location: United States of America; Eastern Time Zone preferred
Annualized starting base pay: $150,000 USD
Company
provides functional clinical research services for biotech, medtech, and specialty pharma companies developing medicines, devices, and diagnostics.
What you will do
- Oversee the planning, execution, and completion of clinical trials in accordance with applicable regulations and ICH/GCP guidance.
- Coordinate trial operations teams to achieve milestones and deliver projects successfully.
- Oversee the development and review of case report forms, source documents, templates, study plans, protocols, and informed consent forms.
- Create and maintain study-specific clinical monitoring plans, including communication and escalation procedures.
- Oversee the evaluation and selection of investigative sites and vendors, and drive timely site activation within quality, scope, and budget parameters.
- Lead and monitor clinical monitoring teams, review data and monitoring reports, optimize monitoring activities, and address quality issues.
Requirements
- Bachelor’s degree or international equivalent, preferably in a clinical, biological, scientific, or health-related field, or an equivalent combination of education, training, and experience.
- 10 years of clinical research experience, including 7 years of global study oversight experience, or proven experience performing all primary job functions.
- Ability to deliver a strong customer experience through positive interactions, quality and timely deliverables, and ownership of assigned tasks.
- Excellent English verbal and written communication skills.
- Strong analytical and organizational skills, with the ability to work independently and manage multiple projects in a fast-paced environment.
Culture & Benefits
- Growth opportunities, skills development, and career support.
- Flexibility and work-life balance support.
- Health insurance, retirement plans, and paid time off may be included in the benefits package.
- Equal opportunity employment compliant with applicable federal guidelines.
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