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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.

Main Responsibilities:

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

Would you like to learn more about CTC and the opportunity outlined? Please, get in contact with us: you may either use the 'apply now' button, or write an email to us.