Senior Clinical Study Manager

Manage clinical studies in accordance with internal standard operating procedures and applicable regulations. Collaborate with internal and external teams to draft protocols, oversee site selection, and lead monitoring activities including report reviews and corrective actions. Track adverse events, oversee safety committees, and manage investigational device allocation. Prepare study reports, organize investigator meetings, and ensure data capture and query management. Develop training plans and review scientific literature to support study design. Document field reports and maintain quality system compliance while suggesting process improvements.