Global Study Lead – FSP Team

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Oversee the operational strategy, planning, and execution of studies from the Commit to Study Initiation (CSI) to study archiving.

• Provide guidance and assistance to the Global Study Manager (GSM) and Study Manager (SM) in the comprehensive delivery of clinical studies.

• Ensure adherence to ICH/GCP standards.

• Responsible for converting asset requirements into study plans and maintaining effective communication with the Clinical Operations Asset Lead.

• Evaluate risks and benefits to make informed decisions that clearly understand the implications on the study and project.

• Maintain effective communication with stakeholders regarding study status, expectations, risks, and issues.

• Build and lead empowered matrix teams effectively.

• Employ innovative strategies for study delivery by leveraging advancements in technology and scientific research.

• Supervise quality initiatives to guarantee protocol adherence and ongoing inspection readiness for assigned studies.

⛳️ Requirements

• Bachelor’s degree in life sciences or a related field.

• Highly skilled strategic leader able to independently manage study accountability across multiple studies or a single large/complex study.

• Extensive experience in clinical development with a proven track record of driving operational study delivery within the pharmaceutical industry or a Clinical Research Organization (CRO).

• Demonstrated operational experience in leading high-performing global study teams in clinical trials.

• Comprehensive understanding of study management, along with knowledge of essential global regulatory guidelines and ICH/GCP.

• Exceptional project management and budget management skills.

🏝️ Benefits

• Health insurance

• Professional development opportunities

• Paid time off