Clinical Operations Manager (COM)

Inactive

Reference Number: 896005-W
Type of placement: Permanent

Introduction:

Our client is a drug discovery and development company located in Basel area, that focuses on developing therapeutic monoclonal antibodies for inflammatory diseases and immune-related disorders.

Main 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 Client 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         

 

Qualifications and Experience:

  • 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