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Clinical Operations Manager - Switzerland  

Novimmune (company)

Posted on : 20 March 2017

Project Description

  • 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.

Major responsibilities:

Study Start-Up Phase Activities to include, but not be limited to:
  • 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 
  • Self-Motivated 
  • 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

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