Remote CNS Clinical Project Manager

Piper Companies; United States; Teletrabalho; USD 150 000 - 200 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Health insurance

Vision insurance

Dental insurance

PTO and holidays

Resumo da oferta

Piper Companies is seeking a Clinical Project Manager, CNS to lead CNS-focused clinical research programs for a leading pharmaceutical/biotech organization. The role manages trial operations, ensures milestones, and coordinates cross-functional teams to drive successful development initiatives.

The ideal candidate has 8+ years in clinical research or PM within pharma/CRO, deep CNS trial experience, strong knowledge of GCP/ICH and FDA regulations, and a track record of managing budgets,

Qualificações

• 8+ years of clinical research or clinical project management experience.
• Extensive CNS clinical trial experience (neurology/psychiatry).
• Strong knowledge of GCP, ICH guidelines, FDA regulations, and trial processes.
• Proven experience managing CROs, vendors, and cross-functional teams.
• Ability to manage complex programs, budgets, and timelines.
• Excellent communication, organizational, and stakeholder management skills.

Responsabilidades

• Lead planning, execution, and oversight of Phase I-IV CNS trials across multiple sites.
• Manage study timelines, budgets, resources, and CRO relationships.
• Collaborate with clinical operations, regulatory affairs, data management, biostatistics, and medical affairs.
• Monitor progress, identify risks, and implement mitigation strategies.
• Ensure compliance with ICH-GCP guidelines and FDA regulations.
• Oversee CRO activities across study start-up, enrollment, monitoring, and closeout.
• Prepare and present project updates and metrics to stakeholders and leadership.
• Support inspection readiness and audit preparation.

Conhecimentos

GCP knowledge

ICH guidelines

FDA regulations

Stakeholder management

Communication

Formação académica

Bachelor's degree in Life Sciences / Nursing / Pharmacy

Advanced degree preferred

Ferramentas

CTMS

EDC platforms

Clinical trial management tools

Descrição da oferta de emprego

Piper Companies is seeking a Clinical Project Manager, CNS to lead CNS-focused clinical research programs for a leading pharmaceutical/biotech organization. The role manages trial operations, ensures milestones, and coordinates cross-functional teams to drive successful development initiatives.

The ideal candidate has 8+ years in clinical research or PM within pharma/CRO, deep CNS trial experience, strong knowledge of GCP/ICH and FDA regulations, and a track record of managing budgets,