Clinical Lead II: Rare Diseases & Oncology

Premier Research Group; United States; Remote; USD 58,000 - 71,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Paid time off

Employee Assistance Program

Job summary

Premier Research is seeking a Clinical Lead II for Rare Diseases / Oncology to join our Clinical Management team. You will help transform life-changing ideas into new medicines and oversee site management and monitoring quality across trials.

You will drive sponsor communications, monitor operational metrics, and ensure audit readiness while collaborating with cross-functional teams in global studies. Competitive benefits are offered.

Qualifications

• Bachelor’s degree or international equivalent in a clinical, biological, scientific, or health-related field.
• At least 2 years as Clinical Lead (global) in a CRO with onsite monitoring experience and ideally Risk-Based Monitoring.
• Must have prior Rare Diseases and Oncology experience, preferably as Clinical Lead managing trials.
• Knowledge of clinical financials, budgets, pass-through and resource management.

Responsibilities

• 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 dashboards/reporting tools.
• Monitors clinical operations metrics, activities and timelines; tracks data entry timelines, open actions, protocol deviations, queries aging, SDR/SDV backlog and monitoring visit report turnaround.
• Ensures a state of audit readiness for both Premier and sites; reviews/responds to audit findings and supports sites in remediation/responses.
• Escalates through established channels CRA/CM/SSU performance concerns, quality events, data breaches, serious breaches or misconduct.

Skills

Oncology

Rare Diseases

Site management

Risk-Based Monitoring

Onsite monitoring

Clinical lead experience

Education

Bachelor’s degree or international equivalent in clinical/biological/health-related field

Job description

Premier Research is seeking a Clinical Lead II for Rare Diseases / Oncology to join our Clinical Management team. You will help transform life-changing ideas into new medicines and oversee site management and monitoring quality across trials.

You will drive sponsor communications, monitor operational metrics, and ensure audit readiness while collaborating with cross-functional teams in global studies. Competitive benefits are offered.