Clinical Project Specialist - 2026 Global Talent Program

About the Role

The Clinical Project Specialist (CPS) supports the planning, execution, and documentation of clinical trials in the United States. Working under the direction of the Director, Clinical Operations, the CPS assists cross-functional study teams, vendors, and clinical sites to ensure trials are conducted in compliance with regulatory requirements and company SOPs. The CPS will help track progress, maintain study documentation, and provide operational support to ensure smooth study execution.

Responsibilities

• Assist with planning, initiation, execution, and closure of US-based clinical trials (Phase I–III).
• Support the development and tracking of study timelines, budgets, and operational plans.
• Coordinate vendor activities and support vendor management (CROs, central labs, clinical trial suppliers, etc.).
• Assist with site management activities, including site selection, start-up, monitoring, and close-out activities.
• Ensure study activities align with FDA regulations, ICH-GCP guidelines, and company SOPs.
• Maintain study documentation (protocols, reports, investigator brochures, etc.) and ensure version control.
• Prepare meeting materials and support cross-functional project team meetings.
• Track and report study progress, issues, and risks to the study team and management.
• Support audit readiness and assist during regulatory inspections.
• Collaborate with and provide operational support to clinical team members.

Qualifications

• Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related field.
• 2 -4 years of clinical research experience, (CRA, CTA, or project coordination experience preferred).

Required Skills

• Familiarity with ICH-GCP, FDA regulations, and US clinical trial requirements.
• Strong organizational skills with attention to detail and ability to manage multiple tasks.
• Effective communication and collaboration skills.
• Proficiency with clinical trial management systems (CTMS), EDC, and MS Office Suite.
• Willingness to travel occasionally (up to 10-15%).

Preferred Qualifications

• Experience in oncology, rare disease, or other specialized therapeutic areas.
• Prior experience in a biotech or pharmaceutical sponsor or CRO environment.