Clinical Lead II - Rare Disease / Oncology

Premier Research Group; United States; On-site; USD 120,000 - 180,000; Full time

Job summary

Premier Research Group in the United States is seeking a Clinical Lead II for Rare Disease/Oncology to drive site monitoring and sponsor communications while ensuring quality and timelines across trials.

You will oversee dashboards/central monitoring, manage data timelines and audit readiness, and bring hands-on RBM and CRO leadership across Rare Diseases and Oncology, including pediatric trials where applicable.

Qualifications

• Bachelor’s degree in a clinical, biological, scientific or health-related field, or equivalent experience.
• At least 2 years as a Clinical Lead in a CRO with on-site monitoring experience and RBM exposure.
• Experience in Rare Diseases and Oncology; CAR-T or Cell Gene Therapy experience preferred.
• Understanding of clinical financials including budgets, pass-throughs and resource management.

Responsibilities

• Serves as the initial point of contact for site management and monitoring quality concerns, initiating and overseeing sPIPs.
• Plans and presents sponsor calls, providing status updates on clinical deliverables.
• Oversees monitoring quality and site management through dashboards and central monitoring plans.
• Monitors operations metrics, timelines, data entry, deviations, queries, SDR/SDV backlog and visit report turnaround.
• Ensures audit readiness and supports site responses to audit findings and remediation.
• Escalates performance concerns through established channels including CRA/CM/SSU.

Skills

Onsite monitoring

Risk-Based Monitoring

Clinical trial management

Sponsor communications

Audit readiness

Education

Bachelor’s degree in clinical/biological field

Tools

Dashboard reporting

Budgeting

Job description

Premier Research is looking for a Clinical Lead II - Rare Disease / Oncology to join our Clinical Management team.

You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.

• We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.

• Your ideas influence the way we work, and your voice matters here.

• As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.

Join us and build your future here.

What You'll Be Doing:

• Serves as initial point of contact for all site management and monitoring quality concerns, including initiation and oversight of site performance improvement plans (sPIP).
• Plans, presents and participates in sponsor calls, representing Clinical and SSU function by providing status updates on clinical deliverables.
• Oversees the quality of clinical monitoring, central monitoring and site management deliverables through the use of dashboards/reporting tools. Strong contributor to the central monitoring plan.
• Monitors clinical operations metrics, activities and timelines on a regular basis; Tracks data entry timelines, open actions, protocol deviations, queries aging reports, SDR/SDV backlog and monitoring visit report turnaround timelines.
• Ensures a state of audit readiness for both Premier and sites. Reviews/responds to audit findings and support sites in remediation/responses to any site audit findings.
• Escalates through the established channels CRA/CM/SSU performance concerns, quality events, data breaches, serious breaches, scientific misconduct or any other event that requires prompt assessment and reporting.

What We Are Searching For:

• Bachelor’s degree, or its international equivalent from an accredited institution, in a clinical, biological, scientific, or health-related field; or equivalent work experience
• At least 2 years of experience as a Clinical Lead (ideally global) gained in a CRO setting and must have prior onsite monitoring experience, ideally to include Risk-Based Monitoring.
• Must have prior experience in both Rare Diseases and Oncology. This will ideally have been gained as a Clinical Lead managing trials vs solely in a CRA capacity. Biliary liver disease therapeutic experience, Oncology experience in CAR-T and / or Cell Gene Therapy in addition to experience working on pediatric trials will be the optimum.
• Working knowledge of clinical financials including understanding of budgets, pass- through and resource management