临床项目经理CPM-Clinical Project Manager
丘以思（上海）医药信息咨询有限公司
- 公司规模：50-150人
- 公司性质：外资(欧美)
- 公司行业：制药/生物工程
职位信息
- 发布日期：2016-10-29
- 工作地点：上海
- 招聘人数：1人
- 工作经验：5-7年经验
- 学历要求：本科
- 职位月薪：25000-36000/月
- 职位类别：其他
职位描述
职位描述：
Job Description：
1. Decide sites for local/regional trials; analyze capability and make recommendation for trial inclusion.
2. Assume ambassadorial role to facilitate communication between sites and Novartis line functions and increase value proposition to investigators.
3. Facilitate preparation and collection of trial documents; resolve problems as required.
4. Supervise trial implementation from project management point of view. Coaching CRO CRA with regard to site initiation, monitoring visits, closeout activities, regulatory assessment, and resolution of site problems to ensure compliance.
5. Track trial execution milestones; identify problems; resolve issues and escalate as appropriate.
6. Manage recruitment and execute contingency plans, as needed.
7. Provides operational input to Clinical Trial Protocols, CRFs and Data Management meetings as required
8. Act as local/regional trial lead. Be responsible for CRO selection for local/regional trials.
9. Act as a mentor to in-sourced CRA for purposes of field training, as assigned.
10. Participate in multi-disciplinary teams within CPO to evaluate and implement process improvement.
11. People management responsibility is optional, depends on reporting line and working needs. If the staff have people management role, then she/he have the responsibility to recruit subordinate, performance review and objective setting. Her/his performance is related to the subordinate’s work outcomes.
13. Ensure studies are being carried out in compliance with local regulations, GCP, Novartis SOP and the protocol requirement.
14. Responsible for study relevant contract management (contract/amendment/task order/change order etc.) and payment validation as needed.
Requirement:
1. BS or higher degree with medical or pharmacological background
2. Fluent English (oral and written)
3. At least 5 years clinical trial experience in multi-national pharmaceuticals company
4. Have oncology project experience
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Job Description：
1. Decide sites for local/regional trials; analyze capability and make recommendation for trial inclusion.
2. Assume ambassadorial role to facilitate communication between sites and Novartis line functions and increase value proposition to investigators.
3. Facilitate preparation and collection of trial documents; resolve problems as required.
4. Supervise trial implementation from project management point of view. Coaching CRO CRA with regard to site initiation, monitoring visits, closeout activities, regulatory assessment, and resolution of site problems to ensure compliance.
5. Track trial execution milestones; identify problems; resolve issues and escalate as appropriate.
6. Manage recruitment and execute contingency plans, as needed.
7. Provides operational input to Clinical Trial Protocols, CRFs and Data Management meetings as required
8. Act as local/regional trial lead. Be responsible for CRO selection for local/regional trials.
9. Act as a mentor to in-sourced CRA for purposes of field training, as assigned.
10. Participate in multi-disciplinary teams within CPO to evaluate and implement process improvement.
11. People management responsibility is optional, depends on reporting line and working needs. If the staff have people management role, then she/he have the responsibility to recruit subordinate, performance review and objective setting. Her/his performance is related to the subordinate’s work outcomes.
13. Ensure studies are being carried out in compliance with local regulations, GCP, Novartis SOP and the protocol requirement.
14. Responsible for study relevant contract management (contract/amendment/task order/change order etc.) and payment validation as needed.
Requirement:
1. BS or higher degree with medical or pharmacological background
2. Fluent English (oral and written)
3. At least 5 years clinical trial experience in multi-national pharmaceuticals company
4. Have oncology project experience
职能类别： 其他
关键字： 临床项目经理 CPM Clinical Project Manager
公司介绍
Clinipace Clinical Research，一个基于科技的全球性全方位服务的数字化合同研究组织（dCRO）。我们开创性的开发了依靠技术创新的CRO服务模式，以满足风险投资支持的，中型的战略性制药，生物技术公司以及医疗器械公司的研发需求。
借助于我们专有的TEMPO?电子化临床试验平台，我们的专家团队用他们丰富的治疗领域知识和见解来帮助生命科学公司制定和执行注册策略，临床开发和上市后研究，以确保药物和医疗器械开发计划的成功。
Clinipace的***目标就是通过开拓创新的技术继续坚定不移地致力于客户的成功，以最具性价比的全球性解决方案服务客户，提供高透明度，灵活和高质量的服务。
我们已经开展了超过1500个全球性的临床研究，完成了超过300个注册和开发策略制定项目。治疗领域涵盖如心血管和代谢，中枢神经系统，皮肤，消化，免疫，感染，***，肿瘤，呼吸，风湿和疫苗（和其他细胞和组织疗法）。
Clinipace刚刚庆祝了他们的10周年。如今，Clinipace其总部设在美国北卡罗莱纳州的Research Triangle Park，为横跨4大洲的27个国家提供服务。
因为对更高的数据准确度，经济高效的解决方案和更低的研发成本的需求在不断的增加，Clinipace还在持续的在全球扩张。
最后, Clinipace以正直透明、追求卓越绩效的企业文化邀请您的加入.
公司主页：*************************
最后, 丘以思以正直透明、追求卓越绩效的企业文化邀请您的加入.
应聘邮箱：kding@clinipace.com
借助于我们专有的TEMPO?电子化临床试验平台，我们的专家团队用他们丰富的治疗领域知识和见解来帮助生命科学公司制定和执行注册策略，临床开发和上市后研究，以确保药物和医疗器械开发计划的成功。
Clinipace的***目标就是通过开拓创新的技术继续坚定不移地致力于客户的成功，以最具性价比的全球性解决方案服务客户，提供高透明度，灵活和高质量的服务。
我们已经开展了超过1500个全球性的临床研究，完成了超过300个注册和开发策略制定项目。治疗领域涵盖如心血管和代谢，中枢神经系统，皮肤，消化，免疫，感染，***，肿瘤，呼吸，风湿和疫苗（和其他细胞和组织疗法）。
Clinipace刚刚庆祝了他们的10周年。如今，Clinipace其总部设在美国北卡罗莱纳州的Research Triangle Park，为横跨4大洲的27个国家提供服务。
因为对更高的数据准确度，经济高效的解决方案和更低的研发成本的需求在不断的增加，Clinipace还在持续的在全球扩张。
最后, Clinipace以正直透明、追求卓越绩效的企业文化邀请您的加入.
公司主页：*************************
最后, 丘以思以正直透明、追求卓越绩效的企业文化邀请您的加入.
应聘邮箱：kding@clinipace.com
联系方式
- Email：kding@clinipace.com
- 公司地址：地址：span广州