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..
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.
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