Bristol Myers Squibb clinical site monitor in Shanghai, China
Identifies, evaluates, and recommends new potential investigators/sites on an on-going basis through medical community networking or internal BMS requests, to assist in the placement of planned clinical studies with qualified investigators.•• Expedites the pre-study and study initiation processes including the conduct of Pre-Study Evaluation and Site Initiation visits. Conducts Site Initiation visits in collaboration with RCO Site Managers and/or CCO Protocol Managers, where applicable, to orient and train site personnel regarding the protocol and applicable regulatory requirements.•• Reviews site activities through frequent visits and contacts to monitor study sites following the monitoring plan and applicable BMS SOPs, to assure compliance with the protocol, ICH and/or FDA GCP Guidelines and other local regulations. This includes, but is not limited to:- Manages multiple protocols, across multiple therapeutic areas, which may require travel, based upon assigned site location and/or geographic territory.- Ensures quality of data submitted from study sites and assures timely submission of data.- Ensures safety and protection of study subjects according to the monitoring plan, BMS SOPs, and ICH and/or FDA GCP Guidelines.- Manages overall activities of site personnel over whom there is no direct authority and motivates/influences them to meet study objectives.- Anticipates and proactively solves study site problems/issues as they occur.Initiates, recommends and communicates corrective actions as needed. Ensures documentedfollow-up to all outstanding issues, within the scope of this position profile. Appropriately escalates serious or outstanding issues to line manager and project team members.- Facilitates the Regulatory Compliance audit process, as needed.- Provides monitoring assistance to site monitor colleagues, as requested.•• Prepares and submits written reports, both monitoring and administrative, in a timely, accurate, concise, tactful and objective manner.•• Interacts and builds professional and collaborative relationships with all study personnel (study coordinator, investigator, pharmacist), peers, and BMS office-based personnel. Uses multiple technologies to maintain open and frequent communication with BMS personnel.•• Resolves most study-related issues independently, with management support. Uses functional expertise and exercises good judgment in seeking appropriate counsel and authorization.•• Exhibits high degree of flexibility when facing changes such as program priorities, protocolmodifications, enrollment challenges, etc.•• Employs good fiscal management to conserve the costs of departmental operation and controls travel expenses.•• • Participates in and or presents in divisional or departmental meetings.• Participates in appropriate professional organizations, meetings, symposia, and continuing education programs to maintain knowledge and expertise across multi-therapeutic areas.•• Participates in departmental/divisional special projects, cross functional work groups, task forces and study feasibilities.•• • Performs other tasks, as assigned or requested by line manager.
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Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.