Manager, Clinical Trial Operations
Job Title: Manager , Clinical Trial Operations - Remote Duration (Contract): 24 Months Client Location: Bridgewater, NJ, 08807 Location Preference: Remote Job Description: Responsibilities: - Supports the Clinical Operations Lead (COL) and/or Senior Clinical Trial Manager (Sr. CTM) with management and execution of all clinical trial activities in compliance with GCP and relevant regulatory guidelines. - Detailed management and oversight of regional trial activities, as supports Clinical Operations Lead and/or Senior Clinical Trial Manager with coordination of cross-functional clinical study team activities to achieve deliverables with high quality, on time, and within budget through information-sharing, ongoing study team meetings/discussions and ensuring effective risk management planning. - Manages regional monitoring oversight of site-level activities related to ongoing and planned trials as assigned. - Supports development of action plans to address protocol compliance, safety, data, and administrative issues with investigator sites. - Participates in 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. - Participates in site feasibility assessments in close collaboration with Clinical Development, Medical Affairs, and Clinical Operations colleagues, including evaluation of site capabilities, patient population access, investigator experience, and therapeutic area expertise, to inform site selection decisions and ensure alignment with study objectives and enrollment targets. - Collaborates with regional MSLs (if applicable) to support investigator engagement activities. - May support organization of investigator engagement meetings or events at industry congresses/conferences. - Participates in Risk-Based Quality Management (RBQM) activities to ensure data integrity and patient safety. - Implements risk-based monitoring (RBM) and centralized monitoring strategies in collaboration with CROs as applicable. NOTE: This is not applicable for early phase trials. - Develops and manages detailed project and other trial-related plans and supports the COL and/or Sr. CTM with planning of and may attend investigator meetings, kick-off meetings, monitoring training, and various CRO