AO Foundation
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.
For more information, visit: https://www.aofoundation.org/
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.
(Senior) Project Manager Clinical Data, 50%-100% (ID1831)
Main Responsibilities
Conducting all tasks regarding clinical data management with AO ITC, such as:
- Set up and validation of clinical study databases in the field of trauma and orthopedics
- Set up, implement and oversee Data Management Plans and Data Validation Plans
- Support and supervision of data cleaning and data clarification activities
- Data base user management for clinical research projects
- Management and maintenance of the AO ITC case report form template library
- Maintenance and further development of Clinical Data Management SOPs
- Line management optional
In General:
- Functional lead of the Clinical Data Management team, including resource planning, cross-functional communication and leading the Data Management Jam Sessions
- Supporting the Head of Clinical Operations in strategical decisions related to the Clinical Data Management team (e.g., development of budgets, project prioritization, further education goals)
Main Requirements
- Degree in Information Technology, Computer Science, Life Sciences, or related field. Equivalent education or certification in clinical data management or database development will also be considered
- Basic level of medical knowledge of advantage
- Extensive experience with data management in clinical research, particularly in utilizing electronic data capture (EDC) systems such as REDCap Academic, REDCap Cloud, and Medidata
- Experience in managing the full data lifecycle from data collection to final reporting, ensuring accuracy, completeness, and consistency. Ability to develop and maintain databases, including designing and implementing case report forms, queries, and reports
- Able to lead the configuration, design, and administration of REDCap and Medidata platforms for clinical trials or research projects. Experienced in implementing study-specific case report forms, including programming automated data validation rules and range checks
- Used to designing, implementing, and monitoring data validation protocols to ensure data integrity and regulatory compliance. Able to conduct thorough data quality checks, consistency checks, and identify discrepancies between data sources.
- Familiarity with data privacy regulations and guidelines, such as GDPR and HIPAA, in the context of clinical data handling
- Proficient knowledge of MS Office work package, especially MS Excel, project management software (e.g., MS Project, JIRA) and clinical data management tools
- Expertise in designing, setting up, and managing clinical databases adhering to global clinical data standards, such as CDISC, including CDASH and SDTM standards
- Demonstrated ability to manage complex clinical data management workflows with strong organizational, planning, and follow-up capabilities
- Attention to detail and reliability
- Collaborative and team-oriented with the ability to work cross-functionally
- Flexibility and customer-oriented mindset
- Strong written and oral communication in English, German skills are of advantage
- Workload percantage: flexible, between 50%-100%
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
- High degree of flexibility regarding working hours and location (depending on operational requirements)
- Generous package of social benefits, including supplementary vacation days and pension scheme contributions
- Internal skills training opportunities and support for continued education
Arbeitsort: 7205Zizers(Home Office möglich)
If you meet the requirements of this challenging opportunity, please submit your complete online application (motivation letter, CV, certificates, reference letters, etc) through our online application system.