Senior Project Manager Clinical Operations

Plan and manage clinical studies within the framework of scientific and legal guidelines. Manage the project portfolio of the assigned clients, coordinating all projects and activities of the assigned clients in order to assist them in achieving their strategic goals. Support the clinical operations team to achieve strategic goals and improve internal processes. Main contact person for budget development and budget tracking. Provide training about budget development and tracking to the team members as required. Prepare and coordinate and if required, conduct site initiation visits, monitoring visits and site close-out visits. Coordinate the development of Clinical Investigation Plans, Case Report Forms and provide operational expertise as required. Coordinate and develop essential documents for the execution of clinical studies. Validation and control of quality of clinical data. Compile and archive study documents. Periodically review study budgets. Provide status information on study data to AO ITC management and clients as required. Maintain contact with Principal Investigators and Study Nurses. Evaluate clinical data in collaboration with the Biostatistician, the Medical Advisor and the Medical Writer. Generate budgets for studies and present them for approval to the clients. Define resource allocation for projects and inform other groups on resources required. Contractual negotiations with the study sites. Represent AO ITC in Research Commissions. Planning and coordination of the annual research budget. Portfolio management, supervision and overview of dedicated research activities at AO ITC. The employee performs all tasks in alignment with the requirements of the ISO 9001 quality management standard and actively contributes to maintaining and improving the quality system. The employee undertakes additional responsibilities and duties as assigned by the line manager to support operational and organizational needs related to the Quality Management System.

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. The AO Innovation Translation Center (AO ITC) streamlines and drives innovation projects. Its activities include the development of clinical solutions with our industrial partner, innovation gathering, proof-of-concept studies, strategic investment in intellectual property, technology, or companies, and evidence creation through clinical research. As part of the AO ITC, Clinical Operations is the AO’s service provider for clinical research. Our clinical research specialists deliver clinical insights that are highly relevant to current surgical practice and enable better patient care by planning and conducting global clinical trials.

• Education: Master of Science (MSc), PhD in a scientific discipline or related healthcare field or equivalent training and experience.

• Minimum 2 - 3 years of experience in managing clinical trials/studies 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 the 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.

• Proficiency in English, any other language will be considered as an added value.