Senior Project Manager Clinical Operations (80-100%)

at  AO Foundation

The AO is a medically-guided, not-for-profit organization, a global network of surgeons, and the world’s leading education, innovation, and research organization specializing in the surgical treatment of trauma and musculoskeletal disorders. We are home to people from all over the world, from different backgrounds, with diverse talents and specialist areas. What binds us together is our passion for excellence, our dedication to our mission of improving patient care, and our understanding that we are stronger together: we are one AO.
In close collaboration with trusted industrial partner, universities and in-house institutes, the AO Foundation constantly develops new operation techniques, implant, instruments and clinical solutions under the medical guidance of independent surgeons. The AO is the leading innovator in the surgical treatment of bone fractures and disorders. Innovation at the AO goes from bench to bedside, including basic research and innovation, product development, and clinical validation. The AO Innovation Translation Center (AO ITC) streamlines and drives innovation projects. As part of the AO ITC, together with Clinical Science, Clinical Operations is the AO’s clinical research provider. With about 30 clinical research specialists (project managers, clinical research associates, study assistances, image research associates, medical advisers, medical statisticians, data mangers, medical writers and quality and vendor managers) we produce clinical evidence by the planning and execution of international clinical studies that is highly relevant to current trauma and orthopedics practices for better patient care.
Employment Type: Permanent
Part-time percentage: 80-100%
This position is located in:Zizers, CH
Experience level: Experienced professional
Please send us your application documents in: English

JOB REQUIREMENTS

• Education: MD, DVM, Master of Science (MSc), PhD in a scientific discipline or related healthcare field or eqivalent training and experience
• Minimum 2 - 3 years of experience in clinical trial experience 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 study team, cross functional team members and external partners/vendors
• Demonstrates problem solving skills, demonstrates leadership skills, self-motivated and adaptable to a dynamic environment
• Flexibility and customer-focused mindset

• Plan and manage clinical studies within the framework of scientific and legal guidelines
• Prepare and coordinate and if required, conduct site initiation visits, monitoring visits and site close-out visits
• Develop and adapt clinical investigation plans, case report forms and documents for ethics commission submission
• Enter and validate clinical data
• Control quality of clinical data
• Compile and archive study documents (e.g. study protocols, clinical data, imaging etc.)
• Periodically review study budgets
• Provide status information on study data to AO Innovation Translation Center (AO ITC) management and sponsor as required
• Maintain contact with principal investigators and study nurses
• Evaluate and interpret clinical data in collaboration with the statistician, the medical advisor and the medical writer
• Review interim and annual registry reports to sponsor in collaboration with the statistician, the medical advisor and the medical writer
• Generate budgets for studies and present them for approval to the sponsor
• Define resource allocation for projects and inform other groups on resources needed
• Contractual negotiations with the sponsor and the study site
• Preparation of all study documents for ethical approval
• Active support of quality management (QM) with reviewing and updating SOPs and related document
• Lead, support and coach a team of clinical research associates, project managers and/or study assistants
• Regularly review the performance of the employees and take necessary measures
• Annual review of the performance and target settings
• Regular meetings with senior project mangers, head clinical operations and head clinical science to discuss project status and resources In General:
• Main contact person on project level for for the internal client AO Technical Commission and the external client DePuy Synthes
• Representative of Clinical Operations, AO ITC in medical expert groups
• Portfolio management, supervision and overview of all internal and external client related clinical research activities within Clinical Operations, AO ITC