Senior Clinical Study Manager

The Senior Clinical Study Manager leads and manages the cross-functional clinical study team, and ensures delivery of clinical study activities to agreed timelines, budget and quality.Ensure knowledge of the patient´s medical need, current clinical landscape and operational feasibility by building relationships with investigators, study site personnel, External Service Providers (ESPs), other external parties and Sobi affiliatesLead and manage the cross-functional clinical study team and supervise that the objectives and responsibilities within the team are fulfilledEnsure delivery of all clinical study activities in accordance to agreed timelines, budget and quality;Ensure identification and documentation of risks to the clinical study activities and deliverablesEnsure that clinical tracking tools and study contact lists are set-up and maintained throughout the clinical study e.g., the Sobi study log and clinicaltrials.govEnsure that study insurance documentation is valid according to current legislationForecast and manage the clinical study team resources and budget for individual clinical studies (budgets in the order of up to 20 MUSD)Coordinate the clinical study activities with respect to Investigational Medicinal Products e.g., ordering, labeling, distribution and extension of expiry dateCoordinate, contribute to and ensure delivery of key clinical study documents such as clinical study protocols, protocol amendments, case report forms, patient information documents and clinical study reports as well as project management plans (e.g., communication, quality and risk management plans).Ensure review, approval and archiving of clinical study documents in accordance with Sobi Standard Operating ProceduresIdentify ESPs for clinical study activities and deliverables together with the clinical study teamDefine the scope for ESPs, lead and manage appointed ESPs and follow-up on ESP performanceIdentify change of scope requirements to the ESP contractsManage ESP contracts, amendments and change ordersCoordinate or manage the investigator/site selection process, as applicable, and approve the selection of investigators/sitesOversee the progress of the clinical study and ensure that all clinical study activities and deliverables are compliant with applicable Sobi SOPs, ICH/GCP guidelines, GPP guidelines and regulatory requirementsProvide clinical study status updates and escalate issues to the Clinical Program LeaderEnsure set-up, maintenance, completeness and archiving of the trial master fileContribute to the development of processes and tools to continuously improve resource utilization and quality of clinical study activities and deliverables