· 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.
· Ensure study milesones and recruitment target achieved. Reviews site activities and quality through on-site visits in addition to remote management capabilities. Monitors study sites following the monitoring plan, BMS 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 enrollment 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.).
· Bachelor’s degree in Pharmacy or relevant, at least 1-2 years of site monitoring experience .
· Ability to manage multiple protocols across multiple therapeutic area, knowledge of clinical trial conduct including HA requirements and ICH GCP.
· Good command of English communication, Excellent communication skills (written and verbal) & Excellent organization skills.
· Reviews site activities through on site/ off site monitoring and contact to monitor study sites as per monitoring plan and the applicable BMS SOPs, to ensure data integrity /patient safety, study milestones/recruitment achieved and maintain strong site relationship.