The Clinical Operations Study Lead is accountable for the end-to-end execution of clinical trials ensuring delivery within budget, timelines, and quality standards
Job Summary
The Clinical Operations Study Lead is accountable for the end-to-end execution of clinical trials ensuring delivery within budget, timelines, and quality standards.
This role requires leading a cross-functional core study team to implement operational plans while leveraging digital tools and innovations like AI for operational excellence.
Candidates must possess solid knowledge of FDA and EMA regulations, GCP guidelines, and demonstrate strong decision-making skills to manage study risks effectively.
Matching Summary
The Clinical Operations Study Lead is accountable for the end-to-end execution of clinical trials ensuring delivery within budget, timelines, and quality standards.
Skills & Requirements
Must-have
Lead cross-functional clinical study team
Manage clinical study budget and timelines
Ensure GCP ICH regulatory compliance
Develop study operational documentation
Oversee vendor selection and performance
Prepare for audits and inspections
Nice-to-have
Experience with digitalization and AI in operations
Lean process improvement expertise
Strong influence in matrixed environment
Project Management Professional certification
Master's degree in scientific discipline
Key Requirements
Bachelor's or Master's degree in scientific discipline
Significant experience in clinical operations
Strong project management and leadership skills
Solid knowledge of GCP, ICH, FDA, and EMA regulations