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Clinical Operations Manager
vor 1 Woche
The Life Science Career Network
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 setup 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 in collaboration with other functions;
- Supervising the deliverables towards the Contract Research Organization (CRO) and external providers selected for the trial, to ensure compliance with study protocol and in accordance with scope of work;
- Leading the development of trialrelated 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 global crossfunctional (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;
- Demonstrate ability to work in multifunctional and crossfunctional teams;
- Able to share expertise and experience with team members and across teams.
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