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Clinical Operations Manager (based in Basel)

CAREER OPPORTUNITY

Clinical Operations Manager (based in Basel)

Novimmune SA is a drug discovery and development company located in Plan-les-Ouates and Basel, Switzerland, that focuses on developing therapeutic monoclonal antibodies for inflammatory diseases and immune-related disorders.

The pipeline is a balance of preclinical and clinical compounds, specific for clinically validated and novel targets. The company has been purposefully targeting a number of orphan drug indications, with the express hope of eventually providing safe and effective treatment options to some of the often neglected populations suffering from rare diseases.

Novimmune 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.

Key responsibilities:

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

1. Assisting in the assessment of potential CRO/third-part vendors for capacity and capability to provide study related services


2. Working with the clinical team to collect and assess feasibility information for potential sites


3. Piloting the budgeting and contracting process to add clinical sites to a clinical study


4. 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:

1. 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


2. 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 Novimmune 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:

1. Review of site activities and status of inter-related departmental activities, so as to approve and authorize site closure



2. Ensure sites are closed appropriately



3. Ensure the completeness of the TMF before final archiving in collaboration with the Clinical Trial Assistant and the Lead COM



4. 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

If your profile matches the above description, please send us your CV, copies of your diplomas and motivation letter in English under the reference COM2018 to the following email address: hr-recruitment@novimmune.com