3 дня назад
Associate Director, Central Monitoring (AI)
164 800 - 247 200$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Associate Director, Central Monitoring (AI) (Clinical Trial Risk Management): Building and operating centralized monitoring capabilities, KRIs, statistical analytics, and dashboards for sponsored clinical trials with an accent on risk-based quality management, regulatory compliance, and cross-functional decision-making. Focus on interpreting multi-source trial data, directing risk-proportionate monitoring changes, leading central monitoring staff, and exploring AI-enabled risk detection.
Location: Remote/Home-Based in Cambridge or London, UK, or Philadelphia, PA, United States. International business travel is required at less than 10%.
Salary: $164,800–$247,200 base pay annually for US-based candidates only, plus potential bonus, equity, and benefits.
Company
is a global biopharmaceutical company developing medicines for serious diseases, with a portfolio spanning sleep disorders, epilepsy, oncology, and neuroscience.
What you will do
- Lead and manage the Central Monitoring function and develop central monitoring staff.
- Define, build, and maintain KRIs, statistical monitoring analytics, and dashboards at study, site, and CRA levels.
- Analyze centralized data trends and translate risk signals into changes to monitoring plans, visit frequency, source data verification, site interventions, and CRA assignments.
- Partner with Trial Risk Management, Site Monitoring, Data Management, Biostatistics, study teams, IT, Business & Technology, vendors, and CROs.
- Lead central monitoring technology platforms and present risk trends and recommended actions to governance forums and senior leadership.
- Maintain inspection-ready documentation and support audits, regulatory inspections, RBQM standards, training, and continuous improvement initiatives.
Requirements
- Typically 8–10+ years of clinical research or clinical operations experience in the pharmaceutical or biotechnology industry.
- Hands-on experience with central or statistical monitoring, risk-based quality management, KRIs, CTMS, EDC systems, and large multi-source clinical trial datasets.
- Strong knowledge of ICH E6(R2/R3), RBQM principles, and applicable global regulatory requirements.
- Prior people management experience, including coaching and developing central monitoring analysts or associates.
- Bachelor’s degree in life science, nursing, or a related discipline.
- Strong analytical, communication, presentation, stakeholder management, and cross-functional collaboration skills.
Nice to have
- Advanced degree such as MS or MPH.
- Experience applying automation, machine learning, or AI to clinical trial oversight.
Culture & Benefits
- Remote/home-based work arrangement.
- Opportunity to influence monitoring strategy across a global sponsored clinical trial portfolio.
- Medical, dental, and vision insurance for eligible US employees.
- 401(k) retirement savings plan and flexible paid vacation for eligible US employees.
- Potential discretionary annual cash bonus or incentive compensation and equity grants.
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