Remote TMF Operations Lead – Global Trials & Compliance

Scorpion Therapeutics; United States; Remote; USD 140,000 - 170,000; Full time

Job summary

Scorpion Therapeutics seeks a TMF Operations Lead to develop and execute strategy ensuring TMF completeness, accuracy, and inspection readiness across BBP-418 clinical trials. You will lead TMF operations, establish governance, monitor quality metrics, and manage CRO performance while improving processes for continuous quality enhancement.

The role focuses on ICH-GCP compliance, risk assessment, and support for audit readiness, with potential travel for meetings as needed in a remote work setup.

Qualifications

• 8+ years in TMF, Clinical Operations, or Clinical Quality supporting global trials.
• Strong knowledge of TMF standards, regulatory guidelines, and GxP practices.
• Excellent organizational, communication, and problem-solving skills.

Responsibilities

• Lead TMF operations strategy across all BBP-418 clinical trials to ensure completeness and accuracy.
• Establish governance, monitor quality metrics, and oversee CRO performance.
• Drive inspection readiness activities and support regulatory inspections.

Skills

Organizational skills

Communication skills

Problem solving

Tools

Microsoft Office

SharePoint

Job description

Scorpion Therapeutics seeks a TMF Operations Lead to develop and execute strategy ensuring TMF completeness, accuracy, and inspection readiness across BBP-418 clinical trials. You will lead TMF operations, establish governance, monitor quality metrics, and manage CRO performance while improving processes for continuous quality enhancement.

The role focuses on ICH-GCP compliance, risk assessment, and support for audit readiness, with potential travel for meetings as needed in a remote work setup.