Clinical Trial Coordinator II - FSP

The Senior Clinical Study Associate (CSA) will independently perform tasks related to planning, and execution of clinical studies, supporting the strategy as defined in the Clinical Development Plan. The role involves supporting day-to-day clinical study activities, regulatory inspection readiness, and collaboration with study teams and CROs.

Location: United States

Responsibilities

• Provide support for critical day-to-day clinical study activities, including regulatory inspection readiness, in accordance with established protocols under the general supervision of the FSP Manager.
• Collaborate with Clinical Operations/Study Manager, study teams, and Clinical Research Organizations (CROs) to support clinical study activities as defined by the clinical trial operating model.
• Perform departmental tasks as needed.

Requirements

• Bachelor’s degree or equivalent international degree.
• 2-4 years’ experience in pharmaceutical industry, clinical research organization, or related role.
• Experience in Phase 2 and 3 studies and global/international studies is advantageous.
• Experience working across multiple therapeutic areas (including oncology) is advantageous.
• Experience in the study start up field.
• Knowledge in global/regional regulatory and compliance requirements for clinical research.
• Demonstrated excellence in task management and cross-functional collaboration.
• Excellent communication skills.
• Excellent teamwork, organizational, interpersonal, and problem-solving skills.
• Fluent business English (oral and written).