Senior Manager, Clinical Trial Operations

Job Title: Senior Manager, Clinical Trial Operations - Remote Duration (Contract): 24 Months Client Location: Bridgewater, NJ, 08807 Location Preference: Remote

Job Description

Responsibilities: - Leads and coordinates the management and execution of all clinical trial activities in compliance with GCP and relevant regulatory guidelines. - May act as Clinical Operations Leader (COL), accountable for trial performance. - Detailed management and oversight of regional/global trial activities, as Accountable for achieving site activations and enrollment milestones in assigned region. - Coordinates cross-functional study clinical team activities to ensure deliverables are completed with high quality, within agreed timelines, and on budget through information-sharing, ongoing study team meetings/discussions and ensuring effective risk management planning. - Develops and manages detailed project and other trial-related plans and documentation and provides regular study status updates to senior management. - Reviews and contributes to the development of clinical trial synopses, protocols, amendments, Case Report Forms (CRFs), IRB/Ethics applications, and recruitment materials. - Creates and/or reviews and approves specific study documents, e.g., informed consent forms, study guidelines, operations manuals, training materials, study plans. - Liaises with CRO and legal to provide language acceptable for IRB's/EC's. - Drives timely and efficient execution of site feasibility assessments in close collaboration with Clinical Development, Medical Affairs, and Clinical Operations colleagues, including