Senior Clinical Project Manager

Job Summary This position oversees conduct of assigned projects, with focus on strategic clients and their clinical trials. Includes interaction with internal team members, clients/sponsors, functional service providers, contractors, and clinical staff. Essential Duties and Responsibilities Includes, but not limited to, the following: • Proactively identifies, analyzes and resolves project issues to ensure that milestones are met and the overall project is completed on time and on budget. • Participates in the identification, selection and management of functional service providers. • Leads functional project teams and reports to team and company management on conduct of assigned projects. • Acts as principal liaison between project/study sponsor(s) and functional service providers, independent consultants and investigative sites. • Assumes responsibility for assigned project management activities (i.e., maintenance of timelines, analysis, creation and maintenance of customized project management tools, etc.). • Oversees and tracks project associated budgets for functional service providers and contractors in the delivery of services. • Maintains close contact with functional service providers, contractors, study investigators and clinical teams to ensure they are in compliance with protocol and overall clinical trial objectives. • Travels as needed to observe and discuss projects, build positive working relationships and maintain enthusiasm regarding clinical trials. • Authors and/or reviews all overall study documents including: protocols, ICFs, CRFs, data management plans, table shells, study reports. • Develops and institutes project metrics to ensure all processes are performed in an efficient, high quality manner. Tracks performance of contractors/functional service providers against project plans, budgets and contract specifications. • Provides status reports and makes presentations to upper management. • Oversees study team consisting of CRAs and project support staff. • Maintains a high level of professional expertise. • Maintains familiarity with clinical/scientific literature and project management best practices. Education, Experience and Required Skills • A bachelor’s degree, or greater, in a natural science or related field and 10 years of related work experience is required. • Experience working with cross-functional teams, consisting of internal and external personnel. • Prior experience managing or overseeing clinical trials, including general understanding of all specialized support functions. • Experience managing budgets is preferred. • Working understanding of the drug development process. • Working knowledge of FDA regulations, guidelines and GCPs (including ICH GCP E6 R3). • Demonstrated exceptional organizational, communication and interpersonal skills. • Able to travel as needed. (Up to approximately 25%) • Strong computer skills required. Must be experienced with word processing, spreadsheet and database applications, including MS Office (Word, Excel, PowerPoint, and Project). Please email your CV to [email protected], if you are interested. Apply tot his job