Clinical Research Pharmacy Project Lead

Kelly Science, Engineering, Technology & Telecom; Bethesda (MD); In loco; USD 120.000 - 170.000; Tempo pieno

Descrizione del lavoro

Kelly Government Solutions in Bethesda, MD, supports NIH with a Clinical Research Pharmacy Project Manager who oversees pharmaceutical operations, protocol development, and regulatory oversight across complex studies.

This role partners with investigators and multidisciplinary teams, ensures FDA, DAIDS, and international compliance, and drives study product management, site readiness, and scientific writing.

Competenze

• Doctor of Pharmacy (PharmD) or equivalent advanced pharmacy degree.
• Experience supporting clinical research studies or pharmaceutical development.
• Knowledge of FDA regulations, GCP, and clinical research operations.
• Strong project management, analytical, and organizational skills.
• Excellent written and verbal communication, including scientific writing.

Mansioni

• Review, plan, and implement clinical trials with cross-functional teams.
• Evaluate study design, feasibility, and pharmaceutical requirements.
• Develop and review study-specific SOPs and operations manuals.
• Forecast study product needs and manage pharmaceutical calculations.
• Monitor project progress and provide status updates to leadership.
• Support regulatory compliance and investigator communication.

Conoscenze

Project management

Regulatory compliance

Clinical research

Pharmaceutical operations

GCP knowledge

Formazione

Doctor of Pharmacy (PharmD)

Descrizione del lavoro

Kelly Government Solutions in Bethesda, MD, supports NIH with a Clinical Research Pharmacy Project Manager who oversees pharmaceutical operations, protocol development, and regulatory oversight across complex studies.

This role partners with investigators and multidisciplinary teams, ensures FDA, DAIDS, and international compliance, and drives study product management, site readiness, and scientific writing.