4 дня назад
Clinical Lead II (Oncology)
116 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Clinical Lead II (Oncology): Overseeing clinical monitoring, site management, quality concerns, and operational metrics for oncology studies with an accent on risk-based monitoring, audit readiness, and clinical deliverables. Focus on improving site performance, tracking protocol and data quality issues, managing escalations, and supporting remediation of audit findings.
Location: United States of America
Salary: Annual base pay from $116,000 USD
Company
supports biotech, medtech, and specialty pharmaceutical companies in developing medicines, medical devices, and diagnostics.
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.
- Monitor operational metrics, activities, timelines, data entry, protocol deviations, query aging, SDR/SDV backlogs, and monitoring visit 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 or 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.
- Strong leadership and organizational skills, with the ability to persuade and motivate team members and clinical sites.
- 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.
Culture & Benefits
- Growth opportunities and support for developing skills and expertise.
- Flexibility and work-life balance support.
- Opportunity to contribute ideas and influence ways of working.
- Benefits may include health insurance, retirement plans, and paid time off.
- Equal opportunity employment compliant with federal guidelines.
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