Project Manager Clinical Operations
vor 2 Wochen
The AO is a medically-guided, not-for-profit organisation, a global network of surgeons, and the world's leading education, innovation, and research organisation specialising in the surgical treatment of trauma and musculoskeletal disorders. We have a global network of over 520,000 health care professionals. Each year we offer over 870 educational events around the world, supported by nearly 8,000 faculty members and attended by over 82,600 participants. We have around 20,000 surgeon members working in the fields of trauma, spine, craniomaxillofacial, veterinary, and reconstructive surgery.
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: 100%- This position is located in: Zizers, CH- Experience level: Experienced professional-
**In this role you will be required to**:
- Plan and manage clinical studies, predominantly in the field of spine surgery, within the framework of scientific and legal guidelines.
- Prepare, coordinate, oversee and if required, conduct site initiation visits, monitoring visits and site close-out visits including report review.
- Manage relevant stakeholders and actively engage them. Examples include the coordination of the internal study team and external CRAs and subcontractors (CROs) involved at the project level.
- Identify challenges in time and respond appropriately by identifying the optimal solution, adjusting it to fit the circumstances, and executing it effectively.
- Coordinate and develop essential documents for the execution of clinical studies.
- Oversee the quality control processes for clinical data, including data validation.
- Compile and archive study documents.
- Serve as the main contact person for budget development and budget tracking.
- Periodically review study budgets, including planned timelines.
- Provide status information on studies to AO ITC management and sponsors as required.
- Maintain contact with study site personnel (Principal Investigators and Study Nurses).
- Evaluate clinical data in collaboration with the Biostatistician, the Medical Advisor, and the Medical Writer.
- Fulfill tasks independently by adhering to applicable guidelines.
- Support the division in achieving its goals.
**To master this challenge, you have**:
**Education**:
- University or similar degree (Masters or PhD in a relevant life sciences discipline).
**Job Specification**:
- Understanding of ICH-GCP.
- Experience in managing research and basic medical knowledge.
- Two years of practical experience with project management, including stakeholder management.
- Good time management and analytical skills.
- Ability to work both independently and in a team.
- Demonstrated ability to collaborate effectively within a team environment.
- Flexibility and a customer-focused mindset.
- Good financial acumen (budgeting).
- Strong written and oral communication skills in English.
**Nice-to-haves**:
- Understanding of ISO14155 and ISO9001.
- Experience in managing clinical studies in industry.
**We offer**
- 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
- Date of publication: Feb 20, 2024
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