Bristol Myers Squibb Clinical Site Monitor in Uxbridge, United Kingdom
Identifies new potential Investigators, through ongoing collaborations with medical monitors (including local staff), field medical personnel, and other medical contacts. Assess potential Investigators and their sites.
Documents the visit, and communicate findings. Provides feedback on Potential Site Assessment findings to collaborators.
Recommends sites for consideration in future studies, as needed.
Expedites the pre-study and study initiation processes including the conduct of Pre-Study Evaluation and Site Initiation visits. Conducts initiation visits in collaboration with Clinical Site Managers, Field Medical and/or Protocol Managers. Orients and trains site personnel regarding the protocol, study related processes and procedures and applicable regulatory requirements.
Reviews site activities and quality through on-site visits in addition to emote management capabilities. Monitors study sites following the monitoring plan, Sponsor SOPs, protocol, ICH/GCP Guidelines and other local regulations as applicable. This includes, but is not limited to: Managing multiple protocols, across multiple therapeutic areas, which may require travel, based upon assigned site location and/or geographic territory.
Ensures safety and protection of study subjects according to the monitoring plan, SOPs, and ICH/GCP Guidelines and local regulations. Ensures quality of data submitted from study sites and assures timely submission of data by using the available systems to follow site activities.
Supervises overall activities of site personnel over whom there is no direct authority. Motivates/influences them to meet study objectives, including enrolment and retention goals. Resolves study site problems/issues as they occur. More complex issues may be resolved jointly with management. Initiates, recommends, documents and communicates corrective actions as needed and follows up to ensure corrective actions are implemented.
Ensures documented follow-up to all outstanding issues/corrective actions, within the scope of this position profile, in the available systems. Appropriately documents and promptly escalates serious or persistent outstanding issues to management and project team.
Facilitates the Regulatory Compliance audit process, as needed.
Prepares and submits written reports, both monitoring and administrative, in a timely, accurate , concise, professional and objective manner.
Identifies opportunities to interact, builds and strengthens professional and collaborative relationships with all internal and external stakeholders (e.g., site and institutional personnel, Thought Leaders, internal colleagues , etc.).
Uses multiple technologies to maintain open and frequent communication with all stakeholders . Exhibits flexibility and adaptability when facing change.
Employs good fiscal management for travel expenses, etc. Ability to perform site management activities, as required.
Performs other tasks, as assigned or requested by line manager.
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