East Coast Global Study Operations Lead

Parexel; Salem (OR); Presencial; USD 120.000 - 180.000; Jornada completa

Descripción de la vacante

Parexel is seeking a Country Study Manager to oversee study-level activities across regulatory, supply, enrollment and timelines. You will manage CRO/vendor relationships, develop training materials, update critical documents and ensure alignment with feasibility strategies and risk reviews.

The role requires 5+ years in clinical research, leadership in global trials, and strong financial, planning, and communication skills. Travel about 10% is expected.

Formación

• Minimum 5+ years of clinical research experience with CRO/biotech/pharma on global trials.
• 2-3 years leading aspects of global clinical trials.
• Experience working with CROs.

Responsabilidades

• Manage integration of project team activities.
• Oversee study operations incl. regulatory submissions, drug supply, enrollment, and budgets.
• Provide input on trial level operational strategies from protocol design to final report.
• Contribute to global subject/patient recruitment plans.
• Manage CRO/vendor identification and day-to-day oversight.
• Create and update critical trial-specific documents.
• Support development of training materials.
• Review budgets, timelines and forecasts for assigned studies.
• Assist with inspection readiness and risk mitigation.
• Interface with internal stakeholders and onboard new team members.

Conocimientos

Leadership

Stakeholder management

Global matrix environment

Mentoring

Organizational skills

Problem solving

Project planning

Communications

Protocol/CSR knowledge

Travel readiness

Educación

Bachelor's degree

Herramientas

MS Office Suite

Descripción del empleo

Parexel is seeking a Country Study Manager to oversee study-level activities across regulatory, supply, enrollment and timelines. You will manage CRO/vendor relationships, develop training materials, update critical documents and ensure alignment with feasibility strategies and risk reviews.

The role requires 5+ years in clinical research, leadership in global trials, and strong financial, planning, and communication skills. Travel about 10% is expected.