南京招聘

• 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:

1. Manages multiple protocols, across multiple therapeutic areas, which may require travel, based upon assigned site location and/or geographic territory.
2. Ensures quality of data submitted from study sites and assures timely submission of data.
3. Ensures safety and protection of study subjects according to the monitoring plan, BMS SOPs, and ICH and/or FDA GCP Guidelines.
4. Manages overall activities of site personnel over whom there is no direct authority and motivates/influences them to meet study objectives.
5. 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.
6. Facilitates the Regulatory Compliance audit process, as needed.
7. 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.

百时美施贵宝是一家以“研发并提供创新药物，帮助患者战胜严重疾病”为使命的全球性生物制药公司。

2019年11月20日，百时美施贵宝成功完成了对新基的收购，将双方在领先的科学、创新的药物和优秀的人才等方面的优势合二为一，打造全球领先的生物制药企业。公司在肿瘤、血液、免疫和心血管疾病等领域处于世界前列，并具有丰富的，且具有行业前景的产品管线。

如今，中国已是百时美施贵宝公司全球重要的研发、生产、营销和创新中心之一。我们致力于满足中国未被满足的迫切的重大疾病需求，引领行业发展，开展多元合作，以帮助中国患者战胜严重疾病。