Senior Clinical Trial Manager (CTM)

Senior Clinical Trial Manager (CTM)  Location:   This position may be performed remotely with travel to the Boston area as needed.    Position Summary  This role will be responsible for project management in the initiation, execution and close out of domestic and international clinical studies, including study concept and design, feasibility assessments, study start-up, contract and budget oversight, data exchange and support of data analysis and interpretation.  This position requires both the knowledge and experience to work within established clinical trial paradigms while exploring and embracing new approaches to conducting research to support data aggregation and analysis to advance patient care. The Sr. CTM will participate on clinical project teams to achieve quality results in a cost-effective and timely manner. S/he will be a key team member to establish key practices and procedures for the clinical team.  Primary Responsibilities  Manage study activities in the successful execution of clinical trials from protocol concept to clinical study report, complying with Good Clinical Practice (GCP) guidelines and international regulations  Manage strategic engagement with key collaborators  Set-up and oversee clinical trial-related trackers such as regulatory documents, trial master file (TMF), startup progress, screening/enrollment, study invoices/payments, project budgets, etc.  Key contributor to IRB/EC and regulatory submissions  Oversee TMF reviews to ensure completeness and inspection readiness  Regularly review documents to ensure adherence to Clinical Operations and/or project specific quality requirements (e.g. SOPs, work practices, training guides)  Identify and mitigate against study risks, escalating as necessary  Direct initiatives to identify and implement best practices and continuous improvement plans in clinical development  Education and Professional Experience  Bachelor’s degree in a scientific field required; advanced scientific degree a plus  5+ years directly managing clinical trials in Sponsor or CRO setting  In-depth knowledge of clinical trial&...