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Clinical trials project manager (mos)

Mos
Opis
Publicada el 27 marzo
Descripción

The Senior Clinical Project Manager reports to the Clinical Operations Manager and is responsible to manage the local and international projects in compliance with contractual requirements, timelines, standard operating procedures and relevant regulations and legislations.He/she leads the internal study team allocated on his/her projects ensuring that all deliverables meet agreed expectations and milestones.Collaborates with major functional areas to identify and evaluate potential issues on the project and ensures the implementation of timely solutions.Proactively manages project level operational aspects including management of trial timeline, budget, and vendors.Forecasts units/hours/generic resources for monitoring activities and analyzes forecasted and worked activities to ensure adherence to contract and budget identifying/escalating any out of scope.Proactively manages and coordinates the overall project activities ensuring that the deliverable meet contractual requirements, timelines, and quality standard;Leads the clinical project team and the various study team meetings;Organizes and prepares kick-of meeting, periodic meeting with Sponsor, Investigators' meeting and internal project meetings ensuring that meeting minutes are appropriately filed in the Trial Master File;Prepares feasibility questionnaires and ensures that the site feasibility and qualification process for identification of qualified investigational sites is conducted as per study/investigation requirements and within timelines;Prepares the project plans, study/investigation specific procedure and tools;Collaborates effectively with the Regulatory and Submission team to speed up the regulatory process and site contract negotiation;Ensures that the monitoring team is trained on study/investigation specific procedures and aspects;Ensures that the enrolment curve is on-track and take actions in case of under-performance; Ensures that the monitoring activities are conducted as per monitoring pla

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Clinical project manager (permanent) - opis
Lugo (27297)
Indefinido
Opis
Ofertas cercanas
Empleo Mos
Empleo Provincia de Lugo
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