Senior Project Manager - Rare Disease

ProPharma Group; New York (NY); Sur place; USD 120 000 - 160 000; Plein temps

Résumé du poste

ProPharma Group seeks a Senior Project Manager to oversee rare disease clinical studies from initiation through closeout. The role involves managing timelines, budgets, stakeholder communication, and regulatory compliance while coordinating cross-functional teams and ensuring study execution meets sponsor requirements.

Based in New York, this position requires strong leadership in TMF management, study planning, and risk assessment to ensure timely delivery and regulatory readiness.

Qualifications

• Clinical operations project management experience in pharmaceutical or biotech settings.
• Knowledge of FDA regulations, ICH-GCP guidelines, and applicable regulatory frameworks.
• Demonstrated ability to manage budgets, timelines, and resource allocation.
• Strong cross-functional communication and stakeholder management skills.
• Experience with clinical trial study plans, TMF management, and study documentation.
• Project planning and risk assessment capabilities.

Responsabilités

• Plan and manage clinical studies from initiation to closeout, monitoring timelines and budgets.
• Serve as primary communication liaison between clinical, internal, and external project stakeholders.
• Develop and maintain study project plans, including site selection, monitoring, and TMF management.
• Oversee study drug and supply management, vendor selection, and investigator meeting execution.
• Monitor regulatory compliance and develop subject recruitment and retention strategies.

Connaissances

Clinical operations

Cross-functional communication

Regulatory compliance

Outils

TMF management

Description du poste

ProPharma Group seeks a Senior Project Manager to oversee rare disease clinical studies from initiation through closeout. The role involves managing timelines, budgets, stakeholder communication, and regulatory compliance while coordinating cross-functional teams and ensuring study execution meets sponsor requirements.

Responsibilities

• Plan and manage clinical studies from initiation to closeout, monitoring timelines and budgets
• Serve as primary communication liaison between clinical, internal, and external project stakeholders
• Develop and maintain study project plans, including site selection, monitoring, and TMF management
• Oversee study drug and supply management, vendor selection, and investigator meeting execution
• Monitor regulatory compliance and develop subject recruitment and retention strategies

Requirements

• Clinical operations project management experience in pharmaceutical or biotech settings
• Knowledge of FDA regulations, ICH-GCP guidelines, and applicable regulatory frameworks
• Demonstrated ability to manage budgets, timelines, and resource allocation
• Strong cross-functional communication and stakeholder management skills
• Experience with clinical trial study plans, TMF management, and study documentation
• Project planning and risk assessment capabilities