обновлено 4 дня назад
Clinical Lead II (Oncology) - Contractor
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Clinical Lead II (Oncology) (Clinical Operations): Overseeing clinical monitoring, site management, quality performance, and operational metrics for oncology clinical studies with an accent on risk-based monitoring, audit readiness, and clinical deliverables. Focus on improving site performance, tracking complex study data and timelines, and escalating quality events, breaches, and compliance concerns.
Location: United States of America; remote-based contract position
Company
supports biotech, medtech, and specialty pharma organizations in developing medicines, medical devices, and diagnostics.
What you will do
- Act as the initial point of contact for site management and monitoring quality concerns, including site performance improvement plans.
- Represent Clinical and SSU functions on sponsor calls and provide updates on clinical deliverables.
- Oversee clinical monitoring, central monitoring, and site management deliverables using dashboards and reporting tools.
- Track clinical operations metrics, data entry timelines, protocol deviations, queries, monitoring backlogs, and report turnaround times.
- Maintain audit readiness, respond to audit findings, and support site remediation activities.
- Escalate performance concerns, quality events, data breaches, serious breaches, and scientific misconduct for assessment and reporting.
Requirements
- Bachelor’s degree or international equivalent in a clinical, biological, scientific, or health-related field, or equivalent work experience.
- At least 2 years of experience as a Clinical Lead.
- Oncology therapeutic-area experience is required; early-phase experience is preferred.
- Strong leadership, organizational, persuasion, and team motivation skills.
- Working knowledge of clinical financials, including budgets, pass-through costs, and resource management.
- Ability to multitask effectively in a fast-paced environment with changing priorities.
Nice to have
- Prior onsite monitoring experience.
- Experience with Risk-Based Monitoring.
- Early-phase oncology experience.
Culture & Benefits
- One-year remote-based contractor position.
- Flexibility and balance to support personal and professional needs.
- Opportunities to develop skills and grow professionally.
- Full-time engagement.
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