About this role
<div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px"><b>Main Responsibilities</b></H2> </div><div><p> </p> <p>Project Management</p> <ul> <li>Plan and manage clinical studies within the framework of scientific and legal guidelines</li> <li>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</li> <li>Support the clinical operations team to achieve strategic goals and improve internal processes</li> <li>Main contact person for budget development and budget tracking</li> <li>Provide training about budget development and tracking to the team members as required</li> <li>Prepare and coordinate and if required, conduct site initiation visits, monitoring visits and site close-out visits</li> <li>Coordinate the development of Clinical Investigation Plans, Case Report Forms and provide operational expertise as required </li> <li>Coordinate and develop essential documents for the execution of clinical studies </li> <li>Validation and control of quality of clinical data</li> <li>Compile and archive study documents </li> <li>Periodically review study budgets </li> <li>Provide status information on study data to AO ITC management and clients as required</li> <li>Maintain contact with Principal Investigators and Study Nurses </li> <li>Evaluate clinical data in collaboration with the Biostatistician, the Medical Advisor and the Medical Writer </li> <li>Generate budgets for studies and present them for approval to the clients </li> <li>Define resource allocation for projects and inform other groups on resources required </li> <li>Contractual negotiations with the study sites</li> </ul> <p> </p> <p>In General</p> <ul> <li>Main contact person for clients </li> <li>Represent AO ITC in Research Commissions </li> <li>Planning and coordination of the annual research budget </li> <li>Portfolio management, supervision and overview of dediacted research activities at AO ITC</li> </ul> <p> </p> <p>Quality System</p> <ul> <li>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.</li> <li>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.</li> </ul></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px"><b>Main Requirements</b></H2> </div><div><p> </p> <ul> <li>Education: Master of Science (MSc), PhD in a scientific discipline or related healthcare field or equivalent training and experience.</li> <li>Minimum 2 - 3 years of experience in managing clinical trials/studies in a pharmaceutical, biotechnology, CRO and or healthcare setting including prior monitoring or equivalent experience</li> <li>Knowledgeable of clinical research operations, including interpretation and implementation of applicable regulations/ICH/GCP, ISO guidelines, is required </li> <li>Demonstrates core understanding of medical terminology, methodological aspects of clinical trial activities</li> <li>Experience in interactions with outside and inside customers </li> <li>Ability to work in complex or multiple projects and exercise critical thinking with minimal supervision </li> <li>Solid attention to detail and excellent organization skills </li> <li>Solid interpersonal skills and communication skills (both written and oral) </li> <li>Ability to establish priorities, operate with a sense of urgency and collaborate (interpersonal, relationship management) with the study team, cross functional team members and external partners/vendors </li> <li>Demonstrates problem solving skills, demonstrates leadership skills, self-motivated and daptable to a dynamic environment </li> <li>Flexibility and customer-focused mindset</li> <li>Proficiency in English, any other language will be considered as an added value</li> </ul></div></div></div>