Quality, Process and Training Specialist

Job Category: Biotech/R&D/Science Career Level: Experienced (Non-Manager) Location: Waltham, MA 02451           Job Description: PAREXEL International Corporation is a leading global bio/pharmaceutical services organization, providing a broad range of knowledge-based contract research, medical marketing and consulting services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, PAREXEL has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Headquartered near Boston, Massachusetts, PAREXEL operates in 55 locations throughout 43 countries around the world, and has over 6,315 employees. For more information about PAREXEL International visit www.PAREXEL.com In conjunction with operational staff develop and implement operational QC processes, to insert quality gates into their operational processes. Verify the use and effectiveness of quality processes. Support Clinical Research Services Management through the provision and coordination of orientation and skills training for operational staff to ensure that clinical trials are conducted according to local regulations, ICH GCP guidelines, standard operating procedures and protocols. Act as Training Coordinator/Manager for the functional group, scheduling and delivering training to meet operational needs. Responsible for providing advice and support to operational staff in process application and adherence; and for identifying areas for efficiency gains and process improvement within operations and training groups, with subsequent development and implementation of action plans. Action plans for process improvement will be communicated to line management. Supports the FGQM in developing and leading the implementation of new systems and tools for FG. ' Education: High Bachelor's degree or equivalent required.' Minimum Work Requirements: 3+ years in Clinical Research field or other similar experience.' Skills: Excellent interpersonal, verbal and written communication skillsClient focused approach to workA flexible attitude with respect to work assignments and new learning Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detailWillingness to work in a matrix environment and to value the importance of teamwork. Must have substantial clinical trials experience, with emphasis on GCP and compliance. Attention to detail and strong organizational skills. Ability to work independently and prioritize workload. IT literate ' Experience with Microsoft based applications and general knowledge of PC functions. Culturally aware and ability to think and work globally. Ability to travel as needed for the position. RESPOND HERE! Respond immediately by accessing the following dedicated online response form which will allow you to cut and paste your resume. This form will go directly and immediately to the hiring authority for this position. Access the online response form at: http://sh.webhire.com/servlet/resp/rf?jobid=2216149&boardid=749