Senior Clinical Trial Operations Lead - Compliance & Delivery

Definium Therapeutics; United States; Remote; USD 120.000 - 170.000; Vollzeit

Zusammenfassung

Definium Therapeutics seeks an experienced Clinical Operations Lead to manage site and country level trial operations, ensuring timely, within-budget deliverables across vendors and CROs.

As the Clinical Operational Trial Lead, you’ll drive cross-functional delivery from protocol synopsis to Clinical Study Report and trial disclosure, coordinating stakeholders and ensuring adherence to regulatory requirements.

Qualifikationen

Aufgaben

• Manage site and country level clinical trial operations, including vendor/CRO oversight and ensuring high-quality deliverables within timelines and budget.
• Serve as the Clinical Operational Trial Lead with accountability for cross-functional delivery from protocol synopsis to Clinical Study Report and trial disclosure.
• Ensure inspection readiness, data integrity, and compliance with SOPs, GCP/ICH guidelines, and FDA and state regulations.

Jobbeschreibung

Definium Therapeutics seeks an experienced Clinical Operations Lead to manage site and country level trial operations, ensuring timely, within-budget deliverables across vendors and CROs.

As the Clinical Operational Trial Lead, you’ll drive cross-functional delivery from protocol synopsis to Clinical Study Report and trial disclosure, coordinating stakeholders and ensuring adherence to regulatory requirements.