Oversee the day-to-day operation of a study or series of studies within one or more clinical development programs. 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 Senior Director and associated departments (e.g. Regulatory, Quality Assurance,) to prepare clinical trial protocols, case report forms, associated documentation and reports. Assists in development of project budgets/contracts. Monitors project status and budget expenditures; identifies problems and recommends solutions. Acts as liaison to departments which support the clinical development process. Coordinates with the Senior Director to establish project standards and strategies for site selection, data collection and monitoring. Assures consistent application of these across all participating investigational sites. Train, supervise and oversee interaction with outside investigators of CRAs, as well as contractsupport personnel to project requirements. Coordinates with the CRA the clinical monitoring plan for the project; tracks frequency of CRA/contractsupport personnel monitoring visits and other CRA/investigational site interactions. In conjunction with the Director, reviews safety and efficacy data for review and approval of monitoring reports. Oversees resolution of data discrepancies; works with CRAs and Sr Surveillance Associate to assure quality and timeliness of adverse events, data collection, and reporting.Work after hours is required frequently to complete work tasks and meet deadlines; overnight travelrequired.
R.N., B.S. N., or Bachelor’s Degree in biological science other other healthcare-related field, or Bachelor’s Degree with equivalent industry-related experience.Additional casework management sciences preferred. Five to ten years pharmaceutical, clinical or bioresearch experience, including three to five years as a CRA and one to two years as a supervisor, team leader, clinical manager, or experience as a Senior CRA with equivalent experience in managing clinical research. 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.