Responsible for supporting the operational management and oversight of clinical trials within assigned countries/regions
Work closely with Clinical Development Operations trial team to support clinical trial-related activities at the country/site level
Manage various aspects of the collaboration with external service providers for clinical services; may participate in the selection of External Service Providers (ESPs) and training of ESP Personnel, contribute to the completion of ESP scope documents and applicable ESP documents (e.g., lab manuals)
Oversee performance of ESPs on a global level to ensure compliance with the clinical study protocol and in accordance with the scope of work (SoW)
Contribute to the development and updating of clinical trial-related risk mitigation and contingency plans, and proactively identify new risks
Support submission to Health Authorities and Independent Ethics Committees/Institutional Review Boards (IECs/IRBs) and perform ongoing quality checks/reviews of the (e)TMF(s) and ensure audit readiness in assigned area of responsibility
Prepare trial budgets, forecasts, timelines and project plans
Bachelor's degree or equivalent university education/degree, preferably in life sciences or healthcare
Experience performing clinical trial management activities with experience in Phase 2 and 3
Detailed understanding of International Council for Harmonization - Good Clinical Practice (ICH-GCP) including international regulatory requirements for the conduct of clinical development programs in key regions (Americas, Europe, Asia Pacific, and Australia)
Experience in managing External Service Providers (ESP) including performance assessments and finance management (invoice review, change order management, budget reforecasting, etc.)
Previous experience working with electronic data capture systems (EDCs), electronic Trial Master Files (eTMFs) and Clinical Trial Management Systems (CTMSs) is preferred
Fluency in English
Projektdauer: 12 MM++
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