1 час назад
Site Management Lead (Clinical Research)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Site Management Lead (Clinical Research) (Clinical Trials): Leading global and area-level clinical site management across study planning, site activation, monitoring, engagement, compliance, and closeout with an accent on study-level strategy, timelines, and inspection readiness. Focus on managing monitoring plans, mitigating operational risks, coordinating cross-functional stakeholders, and maintaining quality deliverables through database locks and study completion.
Location: North Chicago, United States; Madrid, Spain
Company
discovers and delivers innovative medicines and solutions across immunology, oncology, neuroscience, and aesthetics.
What you will do
- Lead clinical site management strategy and operational execution for assigned global and area-level studies.
- Analyze study timelines, assumptions, milestones, and resource requirements to confirm feasible site management deliverables.
- Develop and lead site monitoring and site engagement strategies, including site selection, activation, protocol adherence, and closeout.
- Oversee monitoring activities, status tracking, milestone adherence, data snapshots, database locks, and site closure.
- Identify and mitigate operational risks, contribute to risk assessment and mitigation plans, and escalate compliance issues.
- Drive clinical site management documentation, TMF completeness, and study-level inspection readiness from startup through closeout.
Requirements
- Bachelor’s degree or equivalent, typically in a paramedical or scientific field.
- At least 5 years of industry clinical research experience, with preferred monitoring, project management, or equivalent experience on a global study.
- Experience across study initiation through completion, preferably in Phase II and III studies and Phase I patient studies.
- Knowledge of standard operating procedures, ICH, global regulations, ethics, and compliance.
- Strong communication, leadership, planning, organizational, presentation, and matrix collaboration skills.
- Fluency in English is required. Advanced Microsoft Word, PowerPoint, Excel, and OneNote skills are expected.
Culture & Benefits
- Work in a dynamic, fast-paced clinical development environment.
- Collaborate with global site management leaders, country teams, clinical study teams, and other stakeholders.
- Operate within a matrix structure while working independently and proactively.
- is committed to integrity, innovation, transforming lives, community service, and equal employment opportunity.
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