Senior Project Manager Clinical Operations - AO CMF and AO Trauma

In this role you are required to:

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

Line Management

• Lead, support and coach a team of Project Manager Clinical Operations/Study Assistant’s as well as any future personnel joining his team
• Regularly review the performance of the employees and take necessary measures
• Annual review of the performance and targets settings

In General

• Main contact person for clients
• Represent AO ITC in Research Commissions of AO CMF and AO Trauma
• Planning and coordination of the annual research budget of AO CMF and AO Trauma
• Portfolio management, supervision and overview of all AO CMF and AO Trauma research activities at AO ITC

To master this challenge you have:

• Education: MD, DVM, Master of Science (MSc), PhD in a scientific discipline or related healthcare field or equivalent training and experience."
• 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
• Knowledgeable of clinical research operations, including interpretation and implementation of applicable regulations/ICH/GCP, ISO guidelines, is required
• Demonstrates core understanding of medical terminology, methodological aspects of clinical trial activities
• Experience in interactions with outside and inside customers
• Ability to work in complex or multiple projects and exercise critical thinking with minimal supervision
• Solid attention to detail and excellent organization skills
• Solid interpersonal skills and communication skills (both written and oral)
• 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
• Demonstrates problem solving skills, demonstrates leadership skills, self-motivated and daptable to a dynamic environment
• Flexibility and customer-focused mindset