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Clinical Operations Manager SRS 5587
Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, committed into delivering products on the market over the next 5 years, is looking a Clinical Operations Manager for a 12 months-contract based in Basel area.
Managing the operational trial related activities in close collaboration with other functions, such as site initiations, site closures, eTMF set-up and maintenance, contracts execution and invoices, submissions to Health Authorities, submissions to Ethics Committees/Institutional Review Boards (ECs/IRBs), timely completion of electronic Case Report Forms (eCRFs);
Managing the selection of external vendors and suppliers
Supervising the deliverables towards the Contract Research Organization (CRO) and external providers
Leading the development of trial-related operational documents
Acting as the communication channel for the Clinical Research Associates (CRAs) to ensure data quality is maintained
Approving invoices (e.g. site payments) and ensure related payments in a timely manner
Contributing to the Study Master File (StMF) completeness and readiness for audit/inspection and by performing ongoing quality checks/review
Actively participating to Investigators meeting preparation and presentations and in Site Selection Visits and Site Initiation Visits, as necessary
Qualifications and Experience:
Relevant Swiss working/residency permit and/or Swiss/EU-Citizenship required
Bachelor of Science degree or equivalent University degree in life sciences or healthcare
At least 3 years of experience in managing operational aspects of Phase II and Phase III trials and executing a wide range of clinical trial activities from study start up to clinical study report
Experience in working in regional cross-functional (matrix) and multicultural teams
Experience in selecting and managing External Service Providers (ESP), including performance assessments and finance management
Previous experience working with electronic data capture, electronic Trial Master File (eTMF), and Clinical Trial Management Systems (CTMS)
Excellent knowledge of International Conference on Harmonization-Good Clinical Practice (ICH-GCP) guidelines
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