Senior Clinical Trial Manager

Role: Clinical Operations Specialist supporting global Phase 3 bipolar mania trials for Rapport's precision neuromedicines targeting neuronal receptor complexes. Objectives include managing study start-up, execution, and oversight, ensuring compliance, and optimizing trial performance. Responsibilities encompass developing and tracking study documentation, supporting site activations, overseeing CRO/vendor performance, monitoring timelines and data, maintaining trial documentation, contributing to inspection readiness, and coordinating cross-functional meetings. Requirements: Bachelor's in life sciences or healthcare, 6-8 years of clinical operations experience in biotech or pharma, managing outsourced global trials across Phases I-III, with a strong understanding of GCP, ICH guidelines, and clinical development processes. Experience with CTMS, eTMF, and trial start-up activities is preferred. High-Value: experience in clinical trial management, GCP compliance, global trial oversight, Phase 3, bipolar disorder, CNS therapeutic area. Work setup: hybrid in Boston (onsite Mon-Wed); travel not specified but implied for international trial management.