南平招聘

职位描述：
岗位职责:

The Regional Clinical Operations Manager is a key member of Clinical Research Department. In this position, the Regional Clinical Operations Manager is responsible for leading and manage the regional clinical operation team and provides leadership, strategic direction and oversight for the study, people and stakeholder management activities conducted by his/her team. The Regional Clinical Operations Manager will ensure clinical trials conducted within defined budget and timeline. He/she will lead the process of vendor selection and contract negotiation. The Regional Clinical Operations Manager is responsible to ensure that all the operational activities to have good adherence to ICH-GCP, Chinese legal/regulatory requirements and company policies and SOPs.

1、Strategic Direction:
? Organize, initiate, monitor and manage clinical trials according to China Good Clinical Practice (cGCP) and ICH-GCP, company SOPs and other relevant clinical research guidelines.
? Identifies and implements strategies and tactics to ensure continuous productivity and efficiency gains, and a high performing clinical operations team.
? Accountable for ensuring clinical operation budget forecasts are accurately produced and submitted in time for the functional budget rounds. Ensures adherence to budget forecasts.

2、People Management:
? Develops a highly motivated team through effective leadership, coaching and people management, ensuring an objective and performance-led management culture.
? Accountable for resource management, performance management and career development of Clinical Operations staff.

3、 Stakeholder Management:
? Ensures effective collaboration either directly or through others with investigators, ethics committees, clinical research networks, patient groups and, as required, local Health Authorities, in compliance with company policies and country legislation.
? Develops and maintains excellent relationships and interactions between the Clinical Operations team, Medical team, safety, and other functions.

任职资格:

? Bachelor degree in medicine, pharmacy or other life sciences;
? Minimal 3 years of international pharmaceutical industry experience in clinical study planning, execution activities as manager/director of clinical operations.
? Good leadership skills and can inspiring other people
? Strong insight of the overall drug development process, clinical trial methodology, China regulatory environment, ICH/GCP Guidelines and International regulations
? Good communication and interpersonal skills - works well with others, motivates and encourages
? The ideal candidate is required to have experiences in clinical operations in multi-national companies. Previous Experiences in involving global or regional trials are preferable.

举报 分享

    先声药业是一家快速转型为创新和研发驱动的制药公司，获批建设 “转化医学与创新药物国家重点实验室”，致力于“让患者早日用上更有效药物”。先声药业专注于肿瘤（含细胞治疗）、中枢神经和自身免疫三大治疗领域，拥有多元化且领先的创新产品组合。秉持自主研发与合作研发双轮驱动的策略，先声药业与多家全球医药企业及生物技术公司成为战略合作伙伴，促进全球生命科学成果在中国的价值实现。