Apr 15, 2017

Clinical Trials Program Manager

  • MyNexxtJob
  • Chicago, IL , United States
Full time Biotechnology

Job Description

Chicago , IL , United States   Provide program facilitation and management support to the Clinical Program Leader and research teams planning and executing a multiple study clinical program relating to a major ophthalmology medical device program.   Studies will be carried out at multiple investigatory sites throughout the United States and elsewhere in the world. The Program Manager reports to the Director Clinical Research with a dotted line relationship to the Business Unit Medical Director.   The Program Manager will manage the clinical trial teams to achieve the timely and efficient execution of the worldwide program plan with the highest possible ethical and scientific integrity.  Troubleshoot problems. Facilitate activities that are common across all studies  such as management of an outside Data Safety Monitoring Board and a Clinical Advisory Board  procurement of needed equipment and supplies.   Assist in the development of scenarios for timing and location of potential studies intended to meet the world wide registration and commercialization goals of the project. Manage vendors providing services across studies. Coordinating development of publications and presentations of study data  and the preparation of training materials for investigators.   Assisting with the preparation of regulatory submissions by managing the process of compilation of the materials and by directly contributing written summaries of documents  as needed. Assisting in team-building activities to enhance program effectiveness.   Documenting content of all contacts with investigators or other site personnel  and assuring that all communications are appropriately circulated and filed. Working to help define program roles and responsibilities. Participating in process improvement initiatives. Compliance with departmental SOPs.         

Job Requirements:

The position requires a minimum of 8 years of relevant direct clinical trials experience in the pharmaceutical or medical device industry  with at least four of those years spent directing a clinical research team.   Trial experience is highly desirable. Also  excellent interpersonal skills are required  including the ability to perform well in a highly matrixed environment and the ability to serve as an effective leader of a high-function multi-disciplinary team.   Demonstration of project management capabilities is required. Finally  excellent oral and written communication skills are an absolute requirement. The serious candidate will be highly organized  dynamic  confident  creative and well-disciplined.     A thorough knowledge of and experience with GCPs  ICH and FDA regulatory requirements is requisite  as is great familiarity with Microsoft Project  Microsoft Office  Microsoft Excel and Lotus Notes.  .   • EDUCATION: Minimum of Bachelors degree required


Biological-Chemical Research



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