Clinical Project Coordinator — Trial Planning & Delivery

sumitomopharma; United States; On-site; USD 65,000 - 95,000; Full time

Job summary

Sumitomo Pharma Co., Ltd. is seeking a Clinical Research Professional to assist the Clinical Project Manager in planning, execution, and management of multiple US-based clinical studies.

You will support day-to-day operations, coordinate with CROs, and help ensure quality data and regulatory adherence across trials. The role requires 2+ years in clinical drug development or related research, familiarity with ICH-GCP/FDA regulations, and strong communication within a matrix team.

Qualifications

• BA/BS/MS/PhD in life sciences preferred.
• Minimum 2 years in clinical drug development or equivalent.
• Knowledge of ICH-GCP and FDA requirements.

Responsibilities

• Support the CPM to design, develop, and deliver the clinical study per timelines.
• Coordinate with cross-functional teams to ensure proper execution of trials.
• Monitor data collection status for assigned trials.
• Assist with site lists and site evaluation for inclusion in studies.
• Prepare and review study plans and documents as required.
• Review CRAs/CRO documents for regulatory alignment and protocol consistency.
• Participate in study team and CRO/Vendor meetings.
• Provide program/study updates to the team.
• Coordinate delivery of clinical trial supplies with CROs and partners.
• Assist with change orders and invoice tracking.
• Mentor junior team members when appropriate.
• Perform other duties as requested.

Skills

Excellent written/oral communication

Matrix environment

Cross-functional collaboration

Attention to detail

Regulatory knowledge

Data-driven planning

Education

Bachelor's or higher in life sciences

Tools

Microsoft Word

Excel

PowerPoint

Job description

Sumitomo Pharma Co., Ltd. is seeking a Clinical Research Professional to assist the Clinical Project Manager in planning, execution, and management of multiple US-based clinical studies.

You will support day-to-day operations, coordinate with CROs, and help ensure quality data and regulatory adherence across trials. The role requires 2+ years in clinical drug development or related research, familiarity with ICH-GCP/FDA regulations, and strong communication within a matrix team.