Premier Research is looking for a Clinical Lead II (Oncology) to join our Clinical Management team.
What You'll Be Doing:
- Serve as the initial point of contact for all site management and monitoring quality concerns, including initiation and oversight of site performance improvement plans (sPIP).
- Plan, present, and participate in sponsor calls, representing Clinical and SSU functions by providing status updates on clinical deliverables.
- Oversee the quality of clinical monitoring, central monitoring, and site management deliverables through dashboards and reporting tools.
- Contribute strongly to the central monitoring plan.
- Monitor clinical operations metrics, activities, and timelines on a regular basis; track data entry timelines, open actions, protocol deviations, queries aging reports, SDR/SDV backlog, and monitoring visit report turnaround timelines.
- Ensure a state of audit readiness for both Premier and sites.
- Review and respond to audit findings and support sites in remediation or responses to any site audit findings.
- Escalate through established channels CRA/CM/SSU performance concerns, quality events, data breaches, serious breaches, scientific misconduct, or any other event requiring prompt assessment and reporting.
What We Are Searching For:
- Bachelorโs degree, or its international equivalent, from an accredited institution in a clinical, biological, scientific, or healthโrelated field; or equivalent work experience.
- At least 2 years of experience as a Clinical Lead.
- Prior onsite monitoring experience, including experience with RiskโBased Monitoring, is preferred.
- Strong leadership skills and the ability to persuade and motivate team members and sites to achieve targets.
- Working knowledge of clinical financials, including budgets, passโthroughs, and resource management.
- Ability to multitask and work effectively in a fastโpaced environment with changing priorities.
- Required therapeutic area: Oncology.
Compensation and Benefits:
- Annualized minimum base pay: $116,000 USD.
- Comprehensive benefits package that may include health insurance, retirement plans, and paid time off.
Equal Employment Opportunity Statement:
Premier Research is a proud equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability, or veteran status.
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