Senior Project Manager Clinical Operations (80-100%)

Job Responsibilities :

• 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

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

Working for us, you can expect :

• An interesting and varied job in an exciting and innovative organization
• The opportunity to be part of a highly committed international team
• Modern infrastructure
• Employment conditions which match the requirements and offer a high degree of flexibility regarding working hours and location
Vor 7 Tagen