Senior Site Manager

Há 2 dias

São Paulo, São Paulo, Brasil Caderno Nacional Tempo inteiro

Segmento: Não InformadoAtividades:Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.We are searching for the best talents for these 4 positions of Senior Site Manager (home based).
Principal Responsibilities:Acts as primary local company contact for assigned sites for specific trials.Participates in site feasibility and/or Site Qualification Visit.Attends/participates in investigator meetings, prepares meeting materials, and may present at the IM.Executes activities within site initiation, start-up, monitoring (including remote), management, and close-out according to SOPs, WIs, and policies.
Implements risk-based monitoring and works with sites to resolve issues.Ensures site staff are trained with complete and accurate training records throughout all trial phases.
Collaborates with LTM and central team for site activation to expedite processes.Contributes to recruitment strategies and contingency planning at the site level.Ensures adequacy of trial supplies (IP, lab kits, etc.) and proper handling and storage of clinical drug supplies.Manages clinical supplies, including destruction of unused supplies.Ensures timely data entry, query resolution, and accuracy of data collected at trial sites.Proactively reports AEs, SAEs, and PQCs within required timelines, ensuring consistency with source documents.Maintains complete and timely trial documentation and data in relevant systems.Documents monitoring activities, writes visit reports, and communicates issues to stakeholders.Reviews study files for completeness, ensures archiving and storage requirements are met.Collaborates with LTM on site/study progress and issues.Attends team meetings and training, complies with training requirements.Acts as local protocol expert with sufficient therapeutic knowledge.Works with LTM on CAPA for QA audits and site quality issues, may oversee audit preparations.Prepares sites for close-out and conducts final close-out visits.Tracks costs and ensures payments at the site level, if applicable.Establishes and maintains relationships with investigators, coordinators, and site staff.Participates in Health Authority and IRB submissions as needed.Acts as a point of contact in site management practices.Days of the week: Not informedWorking hours/Period: Not informedInterested parties should apply through the Caderno Nacional portal.
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