Sr Clinical Project Support Specialist - Sponsor dedicated (m/w/d)
IQVIA • Sofia, Bulgaria
Role Description
The **IQVIA Clinical Functional Service Partnerships (Clinical FSP)** department is providing highly skilled professionals to our client’s project team to set-up and execute clinical trials.
**Senior Clinical Project Support Specialist** will provide operational support and coordination for global clinical trials, ensuring efficient trial execution from planning through close-out. Responsible for managing trial-related documentation, systems, communication, and logistics in compliance with SOPs, ICH-GCP, and regulatory requirements, while meeting quality and timeline objectives.
**Main Responsibilities**
• Plan, coordinate, and execute clinical trial activities across regions in compliance with ICH-GCP, ensuring timely and high-quality delivery.
• Maintain and oversee trial documentation (e.g., ISF, TMF, submissions), ensuring completeness, accuracy, timeliness and audit readiness.
• Collaborate with global and regional stakeholders, vendors, and tri...
**Senior Clinical Project Support Specialist** will provide operational support and coordination for global clinical trials, ensuring efficient trial execution from planning through close-out. Responsible for managing trial-related documentation, systems, communication, and logistics in compliance with SOPs, ICH-GCP, and regulatory requirements, while meeting quality and timeline objectives.
**Main Responsibilities**
• Plan, coordinate, and execute clinical trial activities across regions in compliance with ICH-GCP, ensuring timely and high-quality delivery.
• Maintain and oversee trial documentation (e.g., ISF, TMF, submissions), ensuring completeness, accuracy, timeliness and audit readiness.
• Collaborate with global and regional stakeholders, vendors, and tri...