Senior Project Manager Clinical Operations
vor 1 Woche
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
- 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
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