Manage multiple research projects in a fast paced and dynamic environment with a focus on quality, timing and budget. The position involves overseeing the planning, start-up, execution, and data collection and reporting processes. Interface with Directors to provide tactical/operational leadership to members of the study team. Participates in the planning of clinical trials and in establishment of project time lines. Works with the Director, Clinical Research Associates (CRAs), and associated departments (e.g. Regulatory, Quality Assurance, Materials Management) to prepare clinical trial protocols, manage report forms, associated documentation and reports. Monitors project status and budge expenditures; identifies problems and recommends solutions. Acts as liaison to departments which support the clinical development process.
Broad knowledge and cross-functional understanding of clinical trials methodology. Thorough working knowledge of FDA regulations and Good Clinical Research Practices. Able to organize, provide direction, and motivate project team personnel. Able to present complex information and views concisely and persuasively in meetings, discussions and in writing. Problem-solving and negotiation skills. Knowledge of budgetary process. Basic understanding of project management tools/techniques. Able to manage multiple tasks efficiently. Skilled in the use of word processing and spreadsheet software packages; familiar with presentation project management and database management software packages. Deploys limited resources efficiently and creatively to meet aggressive project time lines. Provides guidance, clinical trials management expertise and direction to project CRAs and other study personnel. Coordinates activities of multi-disciplinary project team in a matrix environment.
Bachelor's degree in a biological science or other healthcare-related field. Three to five years pharmaceutical, clinical or bioresearch experience, including one to two years as a supervisor, team leader, clinical manager, or experience as a Senior CRA with equivalent experience in managing clinical research. Previous experience as a clinical quality auditor a plus.
Biotest Pharmaceuticals - 18 months ago