4 дня назад
Clinical Lead II, Oncology (Contract)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Clinical Lead II, Oncology (Contract) (Clinical Operations): Overseeing site management, clinical monitoring, and study quality deliverables for oncology clinical trials with an accent on risk-based monitoring, performance improvement, and audit readiness. Focus on tracking operational metrics, resolving quality concerns, and escalating breaches, misconduct, and other critical events.
Location: Remote-based, United States of America
Company
helps biotech, medtech, and specialty pharma companies develop medicines, medical devices, and diagnostics through clinical research services.
What you will do
- Serve as the initial contact for site management and monitoring quality concerns, including initiating and overseeing site performance improvement plans.
- Plan, present, and participate in sponsor calls, providing status updates on clinical deliverables for Clinical and SSU functions.
- Oversee clinical monitoring, central monitoring, and site management deliverables using dashboards and reporting tools.
- Contribute to the central monitoring plan and track clinical operations metrics, timelines, data entry, protocol deviations, queries, monitoring backlogs, and report turnaround.
- Maintain audit readiness for Premier and clinical sites, and support responses and remediation for audit findings.
- Escalate performance concerns, quality events, data breaches, serious breaches, scientific misconduct, and other events requiring prompt 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.
- Required therapeutic area: oncology.
- 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 contract position.
- Full-time schedule with flexibility and work-life balance.
- Opportunities for professional growth, skill development, and career advancement.
- Employee voice and ideas are encouraged in shaping how work is performed.
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