Detalles del empleo Tipo de empleo: Contrato indefinido
Ubicación: Barcelona, Barcelona provincia
Descripción completa del empleo Global Study Manager Location: Barcelona
Job type: Permanent, Full time
About the job The Global Study Manager (GSM) is responsible for the operational planning, management & execution of clinical study and program(s) within Trial Operations. The GSM is the leader of the clinical study team and is empowered to drive the management & delivery of the study team operational objectives, ensuring all trial deliverables are met according to the study timelines, within budget and having the highest quality standards (GCP / ICH, SOPs / QDs).
The GSM leads the preparation of study related plans and materials, identification of study risks and contingency planning, appropriate escalation of issues, monitors the study planning, manages budget to ensure it is kept within budget and leads the execution of the study with integrity and suitability for regulatory review. The GSM leads cross-functional study teams: responsible for the coordination of internal/ external resources, organization of internal team meetings, and drives and oversees vendors for the flawless execution of studies.
Responsible for management of Clinical and Medical Service Providers, set up & oversight of service providers and ensure adherence to scope of work within timelines and budget. The scope of this position requires excellent communication skills (written and oral), a critical-thinking/problem-solving mindset, and strong leadership to manage across functions and to drive the operational success of study activities.
MAIN RESPONSIBILITIES Leads the Study Team on the Planning and Execution of Clinical Studies: Lead the study team (including representatives from CSUs/affiliates/vendors, Data Management, GPE, Medical Operation, Biostatistics, Clinical Supplies Platform, Regulatory, Pharmacokinetics and other relevant departments) for the operational aspects of the study. Liaise with the feasibility manager to review and assess feasibility. Liaise with clinical buyers to prepare the RFP (request for proposal), review the proposal, participate in the selection of the vendor(s). Liaise with Operational Excellence Center (OpExC) contributors for vendors' activities and deliverables, directly oversee activities and deliverables for vendors not covered by OpExC to ensure performance expectations are met. Liaise with lead Study Data Manager (SDM) for data management activities and deliverables. Liaise with each study team member (Stat, CSD, SDM, RTMs) to consider any input/requirements that could impact the operational conduct of the study. Ensure study progress is aligned with the projections: drive and oversee study timelines, track budget, escalate risk to timelines and budget as needed. Communicate changes and progress. El anuncio original lo puedes encontrar en Kit Empleo: https://www.kitempleo.es/empleo/120863987/uf942-global-study-manager-barcelona/?utm_source=html
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