Clinical Lead II
ΠΡΡΡ & Π‘ΠΎΠΏΡΠΎΠ²ΠΎΠ΄
ΠΠ»Ρ ΠΌΡΡΡΠ° Ρ ΡΡΠΎΠΉ Π²Π°ΠΊΠ°Π½ΡΠΈΠ΅ΠΉ Π½ΡΠΆΠ΅Π½ Plus
ΠΠΏΠΈΡΠ°Π½ΠΈΠ΅ Π²Π°ΠΊΠ°Π½ΡΠΈΠΈ
Location: United States of America
Annualized minimum base pay: $116,000 USD, with actual compensation based on qualifications, skills, competencies, and role proficiency.
Company
supports biotech, medtech, and specialty pharma companies in developing medicines, devices, and diagnostics.
What you will do
- Serve as the initial point of contact for site management and monitoring quality concerns, including site performance improvement plans.
- Plan, present, and participate in sponsor calls, providing status updates on clinical deliverables.
- Oversee clinical monitoring, central monitoring, and site management deliverables using dashboards and reporting tools.
- Monitor clinical operations metrics, data-entry timelines, protocol deviations, queries, monitoring backlogs, and report turnaround times.
- Maintain audit readiness, review audit findings, and support remediation and responses for site audits.
- Escalate performance concerns, quality events, data breaches, serious breaches, and scientific misconduct for prompt assessment and reporting.
Requirements
- Bachelorβs 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.
- Clinical Lead experience in Rare Disease and Oncology is required.
- Prior onsite monitoring experience, including Risk-Based Monitoring, is highly 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 in a fast-paced environment.
Culture & Benefits
- Flexible working practices designed to support work-life balance.
- Opportunities for professional growth and skills development.
- Health insurance, retirement plans, and paid time off may be included in the benefits package.
- Equal opportunity employment compliant with federal guidelines.
ΠΡΠ΄ΡΡΠ΅ ΠΎΡΡΠΎΡΠΎΠΆΠ½Ρ: Π΅ΡΠ»ΠΈ ΡΠ°Π±ΠΎΡΠΎΠ΄Π°ΡΠ΅Π»Ρ ΠΏΡΠΎΡΠΈΡ Π²ΠΎΠΉΡΠΈ Π² ΠΈΡ ΡΠΈΡΡΠ΅ΠΌΡ, ΠΈΡΠΏΠΎΠ»ΡΠ·ΡΡ iCloud/Google, ΠΏΡΠΈΡΠ»Π°ΡΡ ΠΊΠΎΠ΄/ΠΏΠ°ΡΠΎΠ»Ρ, Π·Π°ΠΏΡΡΡΠΈΡΡ ΠΊΠΎΠ΄/ΠΠ, Π½Π΅ Π΄Π΅Π»Π°ΠΉΡΠ΅ ΡΡΠΎΠ³ΠΎ - ΡΡΠΎ ΠΌΠΎΡΠ΅Π½Π½ΠΈΠΊΠΈ. ΠΠ±ΡΠ·Π°ΡΠ΅Π»ΡΠ½ΠΎ ΠΆΠΌΠΈΡΠ΅ "ΠΠΎΠΆΠ°Π»ΠΎΠ²Π°ΡΡΡΡ" ΠΈΠ»ΠΈ ΠΏΠΈΡΠΈΡΠ΅ Π² ΠΏΠΎΠ΄Π΄Π΅ΡΠΆΠΊΡ. ΠΠΎΠ΄ΡΠΎΠ±Π½Π΅Π΅ Π² Π³Π°ΠΉΠ΄Π΅ β