Clinical Trial Lead - Oncology & Rare Disease

Precision Medicine Group; United States; Remote; USD 110,000 - 160,000; Full time

Job summary

Precision for Medicine is hiring a Clinical Trial Manager to lead the operational execution of clinical studies, ensuring adherence to protocol, SOPs, ICH-GCP and regulatory requirements. The role collaborates with the PM, CRAs, QA and sites to drive feasibility, recruitment, monitoring and data quality across studies.

The candidate will oversee monitoring plans, IP management, CAPA, audits and cross-functional activities.

Qualifications

• Bachelor’s degree or equivalent combination of education/experience in science or health-related field.
• Minimum of 5-8 years of clinical research experience or proven competencies for the position with significant clinical monitoring experience.
• Oncology trial experience preferred.

Responsibilities

• Serve as the clinical trial lead responsible for planning, conduct and oversight of the operational portion of studies per defined scope of work.
• Primary clinical point of contact with the client.
• Develop study related clinical documents and training materials.
• Lead internal clinical team meetings and set expectations for CRAs and CTAs.
• Oversee regulatory submissions/approvals with regulatory departments as applicable.
• Coordinate site feasibility, recruitment strategy and budget management with PM and sites.

Skills

Clinical trial management

Client liaison

Budget/variance management

Team leadership

Education

Bachelor’s degree in science/health

Advanced degree preferred

Job description

Precision for Medicine is hiring a Clinical Trial Manager to lead the operational execution of clinical studies, ensuring adherence to protocol, SOPs, ICH-GCP and regulatory requirements. The role collaborates with the PM, CRAs, QA and sites to drive feasibility, recruitment, monitoring and data quality across studies.

The candidate will oversee monitoring plans, IP management, CAPA, audits and cross-functional activities.