Clinical Site Monitor

Clinical Dev

icon-location-marker Guangzhou - CN
Posted 87 days ago Full_time R1517204

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.