- Our company is a Swiss drug discovery and development company, focused on the creation of antibody-based drugs for the targeted treatment of inflammatory diseases, immune-related disorders, and cancer.
- The pipeline is a balance of preclinical and clinical compounds, specific for clinically validated and novel targets.
- Four of these compounds are currently in early clinical development with the anti-IFNg monoclonal antibody program, most advanced, at Phase 2/3, for the orphan drug indication Hemaphagocytic Lymphohistiocytosis (HLH)
- Our company is seeking a Clinical Operations Manager (COM) to join its Clinical Operations Department.
- The role of Clinical Operations Manager is a strategic one within the Clinical Operations team; the COM is responsible for the oversight of the monitoring activities and primarily responsible for site management and relationship building during the conduct of a clinical study support to the Clinical Division.
- Assisting in the assessment of potential CRO/third-part vendors for capacity and capability to provide study related services
- Working with the clinical team to collect and assess feasibility information for potential sites
- Piloting the budgeting and contracting process to add clinical sites to a clinical study
- Development and management of the study Monitoring Plan; carried out in conjunction with other key functional areas, such as those areas responsible for clinical science, IMP supply (packaging/labelling and distribution), drug safety, data management, etc.
Study Conduct Phase Activities to include, but not be limited to:
- Managing the monitor training program for a clinical study; including training at the Investigator Meeting as well as on-site, individual monitor training, as needed
- Site management visits, conducted regularly to ensure site is prepared for the proper execution of the study and to ensure the site stays engaged with company in a positive way, so as to ensure robust study conduct; carried out in compliance with study requirements in order to optimize data utility and integrity
Close-Out Phase Activities to include, but not be limited to:
- Review of site activities and status of inter-related departmental activities, so as to approve and authorize site closure
- Ensure sites are closed appropriately
- Ensure the completeness of the TMF before final archiving in collaboration with the Clinical Trial assistant and the Lead COM
- Other tasks, as delegated by the Lead COM/Head of Clinical Operations
Skills and Competencies:
- A minimum of a Bachelor’s degree in a scientific or health-related field is required; or equivalent experience.
- Minimum five years of experience in the biotech, pharmaceutical, contract research organization arenas; working as a clinical operations manager.
- Or 5+ years as a monitor, ideally with clinical lead experience
- Demonstrated proficiency in all aspects of clinical monitoring and oversight of contract resources
- Fundamental working knowledge of ICH, FDA and EMEA GCPs
- Excellent organizational, written and oral communication skills in English are required, with multiple languages preferred, including French
- Demonstrate proficiency at working alone or within a team setting
- Flexibility and the ability to respond to study challenges
- Travel requirements ~15-25%
- Swiss resident or EU national