Job Opportunities API

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 operations, ICH, GCP Guidelines and other applicable regulatory requirements   Experience directing members of clinical operations teams   Experience working in a team across multiple functional areas (e.g., Quality Assurance, Data Management, Biostats, Medical Writing, Safety, Clinical Supply, Finance)   Other   Essentials   and   Key   Success   Factors   Intellectual curiosity, innovation and creative problem solving with