Clinical Operations
Senior Clinical Operations Manager - 12 month contract
Allschwil
94.91 CHF
Job Title: Senior Clinical Operations Manager Work Location: Allschwil Country: Switzerland Schedule: Fulltime (100%) Duration: 12 months Contractor Rate: CHF 94.91 The Senior Clinical Operations Manager supervises all the operational trial related activities, and the operations team assigned to the trial. The Senior Clinical Operations Manager is accountable for ensuring the delivery of global operational outputs in accordance with the trial timelines and quality standards. Job Responsibilities Provide operational input to the project planning, trial plans and any activity affecting the operational performance and quality of the trial Report all the operational aspects of the trial into the Clinical Trial Team (CTT) leader Lead the operational planning and trial related activities in close collaboration with other functions Supervise the external operations team assigned to the trial, provide clear instructions and set priorities Supervise resolution of operational issues in a proactive and timely fashion Supervise the selection and management of External Service Providers (ESPs) and Clinical Research Organizations (CROs) and the development of trial-related operational documents Manage the clinical trial supplies in close collaboration with Technical Operations: forecasting, ordering, distribution, import/export licenses Oversee information on operational clinical trial level activities for reporting into the CTT (including critical issues and key performance indicators) Ensure adequate trial-specific training is provided to the assigned operations team and CRO/ESPs Supervise the Study Master File (StMF) to ensure completeness and readiness for audit/inspection. Contribute by performing ongoing quality checks/review Actively participate to Investigators meeting preparation and presentations, and to Site Selection Visits (SSVs) and Site Initiation Visits (SIVs), as necessary Support business unit/departments in internal audit preparations and during audits, and ensure the follow-up of and resolution of audit findings related to operational activities Candidate Requirements Bachelor of Science degree or equivalent University degree in life sciences or healthcare 7 years of experience in managing operational aspects of complex Phase II and Phase III clinical trials and global teams Experience in leading global cross-functional (matrix) and multicultural teams Ability to represent Clinical Operations in high level Clinical Development meetings Intensive 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 ICH-GCP Advanced computer skills (e.g., Microsoft Office, Word, Excel and Power Point) • Excellent verbal and written communication skills in English; strong cultural knowledge of national diversities...
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