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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Senior Project Manager Clinical Operations
vor 1 Woche
Zizers, Schweiz AO Foundation VollzeitJob 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...
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Zizers, Graubünden, Schweiz AO Foundation VollzeitThe 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....
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Zizers, Schweiz AO Foundation VollzeitThe 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...
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Regional Manager
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Zizers, Schweiz AO Foundation VollzeitThe 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....
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vor 2 Monaten
Zizers, Schweiz AO Foundation VollzeitJob Description Define and implement the regional Education Events strategy in line with the global strategy Manage the regional Education Events team, monitor team activities and progresses, identify and escalate issues, develop solutions - Facilitate smooth and seamless collaboration of the entire delivery team in the region Ensure the...