Bristol Myers Squibb Clinical Site Manager in Buenos Aires, Argentina
Manages activities at the site and monitors study progress by close collaboration with other key stakeholders (e.g. Medical Monitor, Protocol Manager, Clinical Trial Associates, Contract Administrators, and Site Monitor(s)) as applicable.
Disseminates information to appropriate BMS team members to ensure timelines are met. Proactively identifies and resolves issues noted during site management and informs the appropriate BMS team members .
Applies project management skills to plan for the study milestones and drivers. Keeps all stakeholders informed, escalate issues with proposals and drive solutions in coordination with other departments
Ensures that site management activities, protocol execution and study documentation are in compliance with, ICH-GCP guidelines, BMS SOPs and local regulatory guidelines or regulations.
Shares experiences and best practices through coaching and feedback.
Manages country selection and Target Setting Process at Country level for the assigned study. Coordinates site selection activities by providing guidance as required and by collaboration with other key stakeholders (e.g. Commercial Area, Clinical Trial Assistant, Contract Administrator and Site Monitor(s)).
Reviews documents (protocol and ICF) ensures compliance with country to regulatory requirements..Validates translation and leads regulatory query response . Performs periodic review of the electronic study file to ensure site level documents are in compliance with local regulations and SOP and are on file.
In collaboration with the Contract Administrator assesses whether the budget per patient is suitable to carry out the study, if necessary makes prrotocol budget negotiations with the central team. Participates in contract negotiations with sites, as required.
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