Clinical Operations
Clinical Operations Manager - Allschwil, Switzerland - 12 month contract
Allschwil
CHF 69.49 – CHF 73.72
Job Title: Clinical Operations Manager Work Location: Allschwil Country: Switzerland Schedule: Fulltime (100%) Desired start date: ASAP Duration: 12 months Rate: CHF 69.49 – CHF 73.72 Job Responsibilities The Clinical Operations Manager is 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. For large Phase III or complicated trials, several Clinical Operations Managers might be assigned to a trial for the management of ESPs. • Manage 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 responses timelines • Manage the selection of ESPs in collaboration with other functions • Lead the development of ESP specifications, testing and implementation in collaboration with other functions, and ensure appropriate quality control of deliverables • Supervise 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; identify areas of concern and escalate to the Clinical Trial team (CTT) • Lead the development of trial-related operational documents • Consolidate 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) • Resolve operational issues in a proactive and timely fashion • Act as the communication channel for the Clinical Research Associates (CRAs) to ensure data quality is maintained, in close collaboration with other CTT functions • Approve invoices (e.g. site payments) and ensure related payments in a timely manner • Contribute to the Study Master File (StMF) completeness and readiness for audit/inspection and by performing ongoing quality checks/review • Actively participate to Investigators meeting preparation and presentations and in Site Selection Visits and Site Initiation Visits, as necessary • Mentor team members as needed • Assume responsibility for other project or trial-related duties as assigned ...
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