Clinical Operations Manager
vor 10 Stunden
**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 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 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 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 global 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;
- Demonstrate ability to work in multi-functional and cross-functional teams;
- Able to share expertise and experience with team members and across teams.
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