The Life Science Career Network
CTC are specialised industry experts who can help companies source the best talent and provide reliable HR and consulting services, support varied candidates in finding promising career opportunities and offer the latest in skill development training programmes.
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 for a for a contract based in Basel area for a:
Clinical Operations Manager (4959)
- Managing the operational trial related activities in close collaboration with other functions, such as site initiations, site closures, submissions to Health Authorities, submissions to Ethics Committees/Institutional Review Boards;
- Managing the selection of External Service Providers (ESPs);
- Supervising the deliverables towards the Contract Research Organization (CRO) and ESPs selected for the trial, to ensure compliance with study protocol and in accordance with scope of work;
- Leading the development of trial-related operational documents;
- Contributing to the Study Master File (StMF) completeness and readiness for audit & inspection and by performing ongoing quality review;
- Actively participate to Investigators meeting preparation and presentations and in Site Selection Visits and Site Initiation Visits, as necessary.
Qualifications and Experience:
- Bachelor of Science degree or equivalent University degree in life sciences or healthcare;
- At least 4 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 global cross-functional 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);
- Strong computer skills including proficiency in Microsoft (MS)-based applications (e.g., Word, Excel, and PowerPoint).
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