Main Responsibilities
Project Management
Plan and manage clinical studies within the framework of scientific and legal guidelines Manage the project portfolio of the assigned clients, coordinating all projects and activities of the assigned clients in order to assist them in achieving their strategic goals Support the clinical operations team to achieve strategic goals and improve internal processes Main contact person for budget development and budget tracking Provide training about budget development and tracking to the team members as required Prepare and coordinate and if required, conduct site initiation visits, monitoring visits and site close-out visits Coordinate the development of Clinical Investigation Plans, Case Report Forms and provide operational expertise as required Coordinate and develop essential documents for the execution of clinical studies Validation and control of quality of clinical data Compile and archive study documents Periodically review study budgets Provide status information on study data to AO ITC management and clients as required Maintain contact with Principal Investigators and Study Nurses Evaluate clinical data in collaboration with the Biostatistician, the Medical Advisor and the Medical Writer Generate budgets for studies and present them for approval to the clients Define resource allocation for projects and inform other groups on resources required Contractual negotiations with the study sites
In General
Main contact person for clients Represent AO ITC in Research Commissions Planning and coordination of the annual research budget Portfolio management, supervision and overview of dedicated research activities at AO ITC
Quality System
The employee performs all tasks in alignment with the requirements of the ISO 9001 quality management standard and actively contributes to maintaining and improving the quality system. The employee undertakes additional responsibilities and duties as assigned by the line manager to support operational and organizational needs related to the Quality Management System.
