Senior Clinical Trial Lead & Operations Manager

Precision Medicine Group (New York, United States); Raleigh (NC); Vor Ort; USD 111.000 - 201.000; Vollzeit

Zusammenfassung

Precision Medicine Group is seeking a Clinical Trial Lead to plan, conduct, and oversee the operational aspects of clinical studies in accordance with protocol, SOPs, ICH-GCP, and regulatory requirements. You will coordinate with the client, manage budgets, and ensure timely deliverables across cross-functional teams.

The role requires strong leadership, site start-up oversight, and collaboration with PMs, CRAs, and vendors. Travel domestically and internationally may be necessary.

Qualifikationen

• Bachelor’s degree or equivalent in science/health field; advanced degree preferred.
• Minimum 7 years in clinical research or monitoring with leadership experience.

Aufgaben

• Serve as primary clinical point of contact with the client.
• Collaborate with PM on monthly invoicing and budget variance management.
• Develop study documents and training materials for CRAs and vendors.
• Lead feasibility, recruitment strategy, and site start-up activities.
• Oversee regulatory submissions to authorities and IRBs as applicable.
• Deliver clinical monitoring strategies and quality deliverables.
• Manage IP/pharmacovigilance processes and CAPA where needed.
• Support audits, data quality reviews, and cross-functional coordination.
• May have line management responsibilities and contribute to business development.

Kenntnisse

Client liaison

Budget tracking

Communication

Team leadership

Travel readiness

Ausbildung

Bachelor’s degree in science/health field

Advanced degree preferred

Tools

Microsoft Office

Jobbeschreibung

Precision Medicine Group is seeking a Clinical Trial Lead to plan, conduct, and oversee the operational aspects of clinical studies in accordance with protocol, SOPs, ICH-GCP, and regulatory requirements. You will coordinate with the client, manage budgets, and ensure timely deliverables across cross-functional teams.

The role requires strong leadership, site start-up oversight, and collaboration with PMs, CRAs, and vendors. Travel domestically and internationally may be necessary.