Clinical Operations Manager
Our client is a biotech company that has an exciting pipeline and a product that has recently received FDA Approval. With a focus on developing clinically challenging products within Oncology and Immune related Orphan diseases, they are at the forefront of developing new technologies to generate medicines that have an unmet medical need. A dynamic and innovative company, they are now looking to expand and are actively recruiting for a Clinical Operations Manager for a permanent position to be based in the Basel area.
The ideal candidate should have 5 years of previous experience in clinical research in the pharmaceutical industry environment.
- Assessing potential CRO/third-part vendors for capacity and capability to provide study related services;
- Piloting the budgeting and contracting process to add clinical sites to a clinical study;
- Collecting and assessing feasibility information for potential sites;
- Developing and managing 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;
- 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;
- Managing site visits, conducted regularly to ensure site is prepared for the proper execution of the study and to ensure the site stays engaged with the 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;
- Review of site activities and status of inter-related departmental activities, so as to approve and authorize site closure;
- Ensure the completeness of the TMF before final archiving in collaboration with the Clinical Trial Assistant and the Lead COM;
Qualifications and Experience:
- Scientific or health-related degree
- Demonstrated proficiency in all aspects of clinical monitoring and oversight of contract resources is required;
- Experienced working with the ICH, FDA and EMEA GCPs;
- Fluency in English required, additional language ideal;
- Strong planning and organizing skills, self-motivated , flexibility and the ability to respond to study challenges;
- Travel Requirements 15%;
- Relevant working/residency permit or Swiss/EU-Citizenship required.