CLINICAL OPERATIONS MANAGER

A major pharmaceutical company in Research Triangle Park is looking for a Clinical Operations Manager.A four year degree in a Life Science is required, plus at least three years' experience managing CRA functions, preferably in a CRO or pharmaceutical company. Prior supervisory experience is essential. Extensive knowledge of the clinical development process is essential. Must have thorough knowledge of FDA and ICH guidelines,and GCP regulations. Prior experience selecting and managing CROs required. A thorough knowledge of monitoring practices and site management is required. Previous experience with Clinical Trial Management Systems (CTMS) and Electronic Data Capture (EDC) is helpful. Must be able to prioritise and manage tasks in a rapidly changing environment. Must be able to multitask and solve problems. Must be able to work well in a cross-functional environment. Strong interpersonal, organisational and communication skills are required.
Travel requirement is 30%. This position has 10-15 reports at various levels.