Study Manager - Bay Area

 Smith Hanley Consulting Group has an opportunity available for a Study Manager in the South San Francisco area. The incumbent should possess the following experience:  Performs job duties with minimal guidance Manages system business process maps and process optimization Organize and facilitate cross functional teams to perform continuous process improvement on system applications Collaborates effectively with cross functional training and process departments, such as TIPS, PMST and DLS partners Act as a change agent to ensure minimal organizational disruption during new process implementation Document processes and sub-processes, clearly identifying inter-process relationships (within CISM and across partner organizations) Ensure appropriate documentation and related SOP updates in collaboration with DLS, Dev QA, TIPS and PMST are accurate Collaborates effectively with clinical operations and DATA group systems users In collaboration with CISM Management team, identifies areas for process improvement in CISM department and on system implementation Develop and maintain standard tools and templates to support CISM supported system processes Supports Clinical Information Systems Management and PDIT teams with system assessment, process effectiveness, and to identify improvement opportunities Provide input to the trainers in CISM for training programs for new processes, revisions to current training, new applications, etc. Evaluate system processes used by other companies (through literature review, industry best practices, professional conferences, etc.) to identify and propose adoption of best practices in clinical information system implementation. Qualifications: Bachelor's Degree in Computer Science, Education, Business, or related discipline required 7 years in clinical operations or clinical data management position; or a combination of both areas. Knowledge of Clinical Trials Management Processes. Knowledge of EDC platforms and Clinical Data Management Processes a must. Knowledge of ICH/GCP. Previous leadership of process change initiatives for clinical drug development preferred. Previous experience in clinical trial planning and execution, including site management, vendor management, and cross functional team leadership preferred. Experience with process management tools such as ProVision, Visio, or Nimbus preferred. Training in Regulatory Compliance. Proficient computer skills across multiple applications required. Highly developed and effective written and verbal communication skills. Excellent customer service skills. Advanced leadership skills. High level of expertise in supporting and implementing process implementation material in information systems. Proficiency in prioritization and multitasking to ensure that tasks are completed on time. Effectively collaborates with system users, PDIT, and other functions. Up-to-date knowledge of Clinical Operations, clinical data management and Information Systems. Excellent presentation and meeting facilitation skills. Excellent analytical and problem solving skills. Ability to work in a fast-paced, high-growth environment, and quickly learn new systems and processes. Ability to manage priorities and meet deadlines. Excellent teamwork skills. Excellent attention to detailed required hands on attitude. Excellent computer skills, with experience in evaluating new technologies. If you would like to be considered for this position, please forward your resume to mmurdock@smithhanley.com please reference the job title and number. If you would like to be considered for this opportunity, please forward your resume to the email address provided below. If you meet the minimum requirements someone will be in touch with you to discuss the specific details. Job RefCode: 3025744 Email: Apply by Email