7 часов назад
Associate Director, Central Monitoring (RBQM)
195 500 - 230 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Associate Director, Central Monitoring (RBQM): Designing and leading a centralized monitoring framework for clinical trials with an accent on risk-based quality management, clinical data surveillance, and regulatory compliance. Focus on integrating multi-vendor clinical data streams, governing QTLs and KRIs, investigating systemic data signals, and building a team of Central Monitors.
Location: Remote within US-oriented national and premium markets; travel up to 20%
Salary: $195,500–$230,000 annually, depending on market, qualifications, experience, and geographic location; discretionary bonus and equity award eligible.
Company
is a commercial-stage biotechnology company developing immunotherapies, cell therapies, cancer vaccines, and infectious-disease treatments that harness the natural immune system.
What you will do
- Design, implement, and oversee the Central Monitoring Unit operational framework and integrate it with Field Monitoring.
- Lead the Clinical Data Quality and Governance Board and drive cross-functional agreement on QTLs and KRIs.
- Own Central Monitoring SOPs, work instructions, and Risk Assessment and Categorization Tools.
- Integrate EDC, CTMS, RTSM, eCOA, and Safety Database data into a centralized surveillance engine such as Veeva RBM.
- Escalate systemic issues, partner with Clinical Operations on targeted mitigation, and promote Critical-to-Quality monitoring practices.
- Manage, coach, and evaluate a team of Central Monitors.
Requirements
- Bachelor’s degree in clinical research, science, or a health-related field; a master’s degree is preferred.
- At least 8 years of progressive clinical research experience across Clinical Operations, Data Management, or Biostatistics, including domestic and international clinical trials.
- At least 3 years of direct experience implementing or managing Risk-Based Quality Management frameworks.
- Prior supervisory and department-building experience.
- Expertise in ICH GCP E6(R3) and global regulatory expectations from the FDA, EMA, and MHRA.
- Knowledge of Veeva Vault CDMS, CTMS, RBM, and QMS, plus the ability to interpret clinical data dashboards, visualizations, and KRI/QTL reports.
Culture & Benefits
- Remote work Monday through Friday during standard business hours, with manager-approved flexibility and flexible hours for different time zones.
- Collaborative environment with opportunities to work across different areas of the company.
- Medical, dental, and vision plan options, health and financial wellness programs, and an Employee Assistance Program.
- 401(k) retirement plan with company match, flexible spending accounts, disability coverage, and life insurance options.
- Paid time off, holidays, education savings benefits, legal services, identity theft protection, pet insurance, and employee discounts.
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