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Client:
RBW Consulting LLP
Location:
Job Category:
Other
Job Reference:
253828bd6146
Job Views:
2
Posted:
17.04.2025
Expiry Date:
01.06.2025
Job Description:
Job Title: Clinical Operations Manager
Duration: 12 months
Rate: CHF 69.49 - CHF 73.72
Job Responsibilities:
1. Driving the development of the operational trial related documents and procedures, as well as setting up the ESPs and supervising the deliverables of all ESP related activities, from specifications to close-out.
2. Managing the operational trial related activities in close collaboration with other functions, such as: site initiations, site closures, import/export licenses for materials and IMP, 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), Source Data verification (SDV) progress and query response timelines.
3. Managing the selection of ESPs in collaboration with other functions.
4. Leading the development of ESP specifications, testing and implementation in collaboration with other functions, and ensuring appropriate quality control of deliverables.
5. 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; identifying areas of concern and escalating to the Clinical Trial team (CTT).
6. Consolidating information on operational clinical trial level activities for reporting to the CTT by the Senior Clinical Operations Manager (including critical issues and key performance indicators).
7. Resolving operational issues in a proactive and timely fashion.
8. Acting as the communication channel for the Clinical Research Associates (CRAs) to ensure data quality is maintained, in close collaboration with other CTT functions.
9. Approving invoices (e.g. site payments) and ensuring related payments in a timely manner.
10. Actively participating in Investigators meeting preparation and presentations and in Site Selection Visits and Site Initiation Visits, as necessary.
11. Mentoring team members as needed.
12. Assuming responsibility for other project or trial-related duties as assigned.
Candidate Requirements:
1. Bachelor of Science degree or equivalent University degree in life sciences or healthcare.
2. 4 years of experience in managing operational aspects of Phase II and Phase III trials and executing a wider range of clinical trial activities from study startup to clinical study report.
3. Experience in working in global cross-functional (matrix) and multicultural teams.
4. Experience in selecting and managing External Service Providers (ESP), including performance assessments and finance management.
5. Previous experience working with electronic data capture, electronic Trial Master File (eTMF), and Clinical Trial Management Systems (CTMS).
6. Excellent knowledge of International Conference on Harmonization-Good Clinical Practice (ICH-GCP) guidelines.
7. Strong computer skills including proficiency in Microsoft (MS)-based applications (e.g., Word, Excel, and PowerPoint).
8. Excellent verbal and written communication skills in English; strong cultural knowledge of national diversities.
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