Project Manager (Argentina)

Description The Project Manager ensures the successful initiation, planning, execution, monitoring, controlling and closure of assigned clinical research projects. The Project Manager I must ensure compliance with the study budget, project scope and timelines and in accordance with applicable standard operating procedures (SOPs), good clinical practices, regulatory and study-specific requirements. These tasks are done under close supervision by Senior Project Manager/Program Director and/or Associate Director, Project Management This role will be perfect for you if: - We can count on you to deliver results while using a disciplined approach to project management - You are looking for the next career step to prepare you to become a project manager. - You are knowledgeable about clinical research projects and looking to continue learning. - Working in an organization that is driven by science and innovation and completing meaningful work is important to you. RESPONSIBILITIES - May serve as primary contact for the Sponsor, vendors and internal team throughout the study. - Coordinates tasks and deadlines between the different departments involved in the project. - Oversees project coordinators, SSU team members, RDA and RAC resources to ensure correct prioritization of site activation activities amongst team members - Interacts with vendor management to ensure vendor supplies and services are coordinated for with site activation timelines - Escalates to project manager II when site activation timelines are at risk or cannot be maintained. - Assists with managing the needs and expectations of the Sponsor and other internal and external project stakeholders. - Assists with ensuring all team members are adequately trained on the project. - May plan the activities and resources (e.g. internal and external resources, equipment, etc.) required for the project. - Manages the quality of assigned work and deliverables - Assists with providing project status updates to external and internal stakeholders - Ensures assigned tasks are completed in compliance with the study budget, project scope and timelines and in accordance with applicable standard operating procedures (SOPs), good clinical practices, regulatory and study-specific requirements. - Reconciles study trackers - Assists with analyzing discrepancies between planned and actual results and participates in the development and implementation of corrective actions to be taken as needed. - Assists with enforcing effective change control and risk management throughout the project. - Reviews and may assist in the drafting of project operational plans, processes, and manuals as applicable (e.g., project management plan, monitoring plan, etc.). - Assists with ensuring that study specific documents and project deliverables (e.g., protocol, informed consent form, electronic case report form (eCRF), tables/listings/figures (TLFs), clinical study report, etc.) meet applicable country requirements. - Oversee activities related to sites selection (feasibility questionnaires, sites selection, planning of site qualification visits) - Monitors patient recruitment, subject status, and follows up with sites on recruitment strategy plan. - Participates in the planning and conduct of Investigator’s Meeting. - In collaboration with the Regulatory Affairs group, may oversee activities related to central ethics and regulatory submissions. - Ensures collection of required essential documents from the sites prior to study initiation and maintains of currency of site level documentation throughout the study. - May assist the project manager II with quality reviews and or audits of the Trial Master File (TMF) to ensure inspection readiness. - May support clinical monitoring activities, such as CRA training, visit report review, site letters, and escalated site issues - May track site qualification, initiation, routine and close-out visits, project-specific training, monitoring