Clinical Site Monitor
Bristol-Myers Squibb Company
Guangzhou, China
3天前

Bristol-Myers Squibb is a global Biopharma company committed to a single mission : to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference.We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development.

Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

  • 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 documented
  • follow-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, protocol
  • modifications, 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.
  • Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

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