Clinical Lead II: Rare Disease & Oncology

11 Premier Research International LLC; North Carolina; Sur place; USD 120 000 - 180 000; Plein temps

Résumé du poste

Premier Research in North Carolina is seeking a Clinical Lead II for Rare Disease / Oncology to join our Clinical Management team. You will help biotech and pharma partners transform ideas into new medicines and devices, delivering patient-focused clinical programs.

Responsibilities include overseeing site management, monitoring quality, sponsor communications, and escalation of issues. Experience leading trials, risk-based monitoring, and onsite oversight in CRO settings is required.

Qualifications

• Bachelor’s degree in a clinical, biological, scientific, or health-related field (or international equivalent).
• At least 2 years as Clinical Lead (ideally global) in a CRO with on-site monitoring experience including Risk-Based Monitoring.
• Must have prior experience in Rare Diseases and Oncology.
• Clinical Lead managing trials preferred over CRA-only experience.
• Experience with biliary liver disease or pediatric trials is a plus.

Responsabilités

• Serve as the initial contact for site management and monitoring quality concerns (sPIP).
• Plan, present, and participate in sponsor calls, providing status updates on clinical deliverables.
• Oversee the quality of clinical monitoring, central monitoring, and site management deliverables.
• Monitor operations metrics, timelines, data entry, and audit readiness; escalate issues as needed.
• Review audit findings and support sites in remediation and responses.

Connaissances

Onsite monitoring

Global Clinical Lead experience

Risk-Based Monitoring

Rare Diseases experience

Oncology experience

Formation

Bachelor’s degree in clinical/biological/scientific/health-related field

Description du poste

Premier Research in North Carolina is seeking a Clinical Lead II for Rare Disease / Oncology to join our Clinical Management team. You will help biotech and pharma partners transform ideas into new medicines and devices, delivering patient-focused clinical programs.

Responsibilities include overseeing site management, monitoring quality, sponsor communications, and escalation of issues. Experience leading trials, risk-based monitoring, and onsite oversight in CRO settings is required.