Candidates must be located in the United StatesReporting to the Associate Director of Clinical Operations, the Clinical Trials Manager will be accountable for managing the clinical operation activities for clinical studies. This person will be key in driving the clinical studies day to day activities, ensuring on time delivery of main clinical milestones, as well as respect of GCP.Responsibilities:Lead, manage and co-ordinate the conduct of assigned clinical trials from study start-up to close out in accordance with ICH-GCPOversees the quality of the clinical operations for the studies he/she is in charge ofEnsure that study is Inspection ready through the study lifecycle and partake in CAPAs when neededCollaborates with cross functional stakeholders to ensure timely and on budget execution of clinical trial deliverablesCollaborates with Clinical Science, data management and statisticians ensuring data base maintenance, interim and final database locks.Manages clinical sites and academics institutions, ensures adherence for keeping clinical records, source documents, data entry, manages clinical trial logistics, applications (IRB, local agencies)Planning, management and reporting of clinical studies through oversight of cross-functional study activities, identification and resolution of issues, and communication of study timelines/deliverablesEnsuring implementation and conduct of study(ies) in accordance with ICH-GCP guidelinesEnsures development, review, finalization and delivery of high quality key study documents in order to meet study timelines.Manages CRFs creation, implementation, collaborating closely with data management for the study activitiesEnsures accurate maintenance and archiving of study recordsOversees TMFManages study budget and timelinesManagement of vendors, including a CRO, to the required standardsQualifications:Bachelor’s degreeExperience & knowledge of clinical project management8+ years of relevant and progressive clinical trial management experienceExperience & knowledge of clinical project managementExperience in oversight of external vendors (e.g. CROs, central labs, etc.)Experience in running a trial from start to finish; initiating the trial that includes protocol development, ICF generation, site feasibility/start up training, contract and budget negotiation, vendor management, CRF design, maintaining a trial and study close out.Strong understanding of clinical trials processes, protocols, and medical terminologyProtocol development experience25% travel required