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Lvt446 Senior Clinical Project Manager
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.ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture. We are looking for a dynamic person to join our in-house team as a Senior Clinical Project Manager to join their internal team in Spain. You will work on projects from our varied client base, ranging from small to big pharmaceutical, biotechnology, medical device and consumer health companies. As Senior Clinical Project Manager you will be responsible for managing the clinical projects ensuring quality of the services in accordance with contractual obligations, applicable SOPs, ICH-GCP guidelines and other applicable regulations.Join our team: you can be part of making a difference in peoples' lives and experience a fulfilling and rewarding careerMain Job Tasks and Responsibilities Supervise the assigned clinical research projects.Coordinate and maintain the planning of the activities for the assigned projects.Manage the correct development of the clinical project, interacting with the Sponsor and the Investigators and properly coordinating the project team members.Keep professionally abreast of all scientific, regulatory and operational aspects relevant to the clinical projects assigned.Verify the assigned project activities plan, timelines and the related critical state.Manage the budget for the project.Share the workload and the performance of the project team with the assigned Clinical Research Department Director.Supervise Clinical Research Associate (CRAs) activities, ensuring compliance with ICH-GCP guidelines and applicable laws and regulations.Supervise the Clinical Trial Administrators (CTAs) and CRAs in terms of local authorities approval activities.Supervise the CTAs in archiving activities.Supervise the overall management of the project, including the assigned Biometrics team and all other project team members involved in the delivery of specific activities (such as Safety, Regulatory, etc.).Assist the Medical Monitor in preparing protocols, Case Report Forms (CRFs) and final Clinical Study Reports (CSRs).Arrange and collaborate with the assigned Clinical Research Department Director, in identifying project specific trainings of the project team and in delivering them.Participate in Monitor's and Investigator's Meetings.Organise and/or take part in the periodic project update meetings.Provide project updates to the Sponsor and to the Project Director/Leader and to the Clinical Department Director.Inform Project Director/Leader and the Clinical Department Director about any issues that can jeopardise the business relationship with the Sponsor.Perform, if necessary, co-monitoring visits for the assigned clinical projects.Carry out the monitoring of the sites for the assigned projects, when requested and if applicable.May tutor Project Coordinators/Project Managers
