4 дня назад
Clinical Trial Manager, CKD (Biotech)
143 000 - 175 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Clinical Trial Manager, CKD (Biotech): Driving Phase 2 chronic kidney disease clinical trials from protocol development through database lock and study report completion with an accent on vendor management, site oversight, and cross-functional clinical operations. Focus on implementing ICH GCP-compliant studies, coordinating trial materials, and managing milestones across internal teams, CROs, and investigative sites.
Location: Hybrid, South San Francisco, California, United States; travel required as needed for project needs.
Annual salary: $143,000–$175,000 for employees located in the San Francisco Bay Area, plus eligibility for an annual performance bonus.
Company
is a clinical-stage biopharmaceutical company using human genetics to develop precision medicines for kidney and metabolic diseases.
What you will do
- Drive execution of one or more Phase 2 chronic kidney disease clinical trials from protocol development through first patient in, interim analysis, database lock, and study report completion.
- Manage CROs, key external vendors, and global investigative sites.
- Oversee site monitoring activities and ensure compliance with study protocols, SOPs, and ICH GCP guidelines.
- Coordinate development of clinical trial materials, including CRFs, informed consent forms, and patient diaries.
- Represent Clinical Operations on cross-functional teams and collaborate with Clinical Science colleagues, KOLs, and investigators.
Requirements
- Degree in a scientific discipline or health-related field.
- At least 4 years of clinical research experience, including 2 years as a Clinical Trial Manager at a biopharmaceutical company or CRO.
- Experience planning, executing, monitoring, and managing clinical trials from start-up through close-out.
- General knowledge of FDA regulatory requirements and ICH GCP guidelines.
- Strong organization, prioritization, communication, problem-solving, negotiation, and collaboration skills.
- Experience with clinical trial databases such as Medidata Rave or Veeva, plus proficiency with Microsoft Office, Project, Word, Excel, PowerPoint, and Outlook.
Nice to have
- Experience planning and executing Phase I–II clinical trials.
Culture & Benefits
- Collaborative environment focused on discovering and delivering transformative medicines to patients.
- Culture built around resilience, teamwork, bold decision-making, integrity, and patient impact.
- Medical, dental, vision, and mental health benefits for eligible employees.
- Equity incentive plan, 401(k) program with employer match, holiday policy, and paid time off.
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