Clinical Trial Manager/Senior Clinical Trial Manager (Clinical Research)
Мэтч & Сопровод
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Описание вакансии
TL;DR
Clinical Trial Manager/Senior Clinical Trial Manager (Clinical Research): Leading the operational planning, conduct, and oversight of clinical studies ensuring compliance with ICH-GCP and regulatory requirements with an accent on site feasibility, risk management, and monitoring strategies. Focus on coordinating cross-functional teams, managing clinical documentation, and ensuring data quality across multiple study sites.
Location: Remote (United States)
Salary: $100,700 - $200,900 USD
Company
is a specialized provider of clinical research services focused on precision medicine.
What you will do
- Lead the planning, conduct, and operational oversight of clinical studies per defined scope of work.
- Develop key study documents including clinical plans, Informed Consent Form templates, and monitoring manuals.
- Drive site feasibility processes and develop country-specific recruitment and retention strategies.
- Manage eTMF implementation and collaborate with QA to develop and implement CAPA plans.
- Oversee submissions and approvals to Competent Authorities and IRB/Ethics Committees.
- Coordinate with Project Managers on monthly invoicing and clinical budget variance management.
Requirements
- Bachelor’s degree in science or health-related field (Advanced degree preferred).
- Minimum 7 years of clinical research experience with significant clinical monitoring experience.
- Must be based in the United States.
- Mastery knowledge of ICH-GCP and relevant regulatory guidance.
- Ability to travel domestically and internationally including overnight stays.
Culture & Benefits
- Discretionary annual bonus.
- Comprehensive health, life, and disability insurance.
- Retirement savings benefits.
- Parental leave and paid time off for sick leave and vacation.
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