Lead CRA
希奥莱姆医药科技咨询（上海）有限公司
- 公司规模：500-1000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：2014-07-15
- 工作地点：北京
- 招聘人数：1
- 学历要求：本科
- 职位月薪：面议
- 职位类别：临床研究员
职位描述
? In a matrix environment, manage, lead, motivate, and support the assigned project CRA team.
? Support PL or take over responsibility for time, finance, and risk management on allocated projects.
? Oversee visit management activities, for example, visit projections, site visit report submission/review/finalization, and manage CRA
monitoring schedules (e.g. ensure appropriate monitoring frequency per contract/budget).
? Provide project training and ensure documentation of training for all project team members throughout the project.
? Communicate effectively and timely with sponsors, third party vendors, and/or other internal departments as defined in the approved
project plans.
? Provide additional project support per the contract/Scope of Work.
? Complete all other assignments given by management or as business needs require.
? Support PL or take over responsibility for time, finance, and risk management on allocated projects.
? Oversee visit management activities, for example, visit projections, site visit report submission/review/finalization, and manage CRA
monitoring schedules (e.g. ensure appropriate monitoring frequency per contract/budget).
? Provide project training and ensure documentation of training for all project team members throughout the project.
? Communicate effectively and timely with sponsors, third party vendors, and/or other internal departments as defined in the approved
project plans.
? Provide additional project support per the contract/Scope of Work.
? Complete all other assignments given by management or as business needs require.
公司介绍
Established in 1985, Theorem Clinical Research is one of the industry’s leading full-service, global CROs. Theorem provides core CRO services for Phases I to IV, but with niche business units in the areas of Technical Services, Medical Device and Pharmaceutics.
So what makes us different? Theorem can manage even the most complex project--from study design to product launch and beyond. Our clients see us as “the right size” CRO—big enough to successfully manage your large global trials, but with a personalized service level you might associate with a smaller organization. And we execute with speed, flexibility and an attention to detail that drives high-quality performance. Additionally, we have unique strengths in Asia Pacific and Latin America.
Our comprehensive clinical service offering includes the following:
? Project Management
? Clinical Monitoring*
? Clinical Data Management*
? Regulatory Affairs*
? Clinical Quality Assurance
? Safety Surveillance/Pharmacovigilance*
? Biometrics*
? Clinical Writing
? Investigator Agreements
? Medical Affairs
? Patient Recruitment
The Theorem Clinical Research name is new. But it is built on a long history of delivering exceptional services and support for all phases of clinical research. Before launching in 2011, Theorem Clinical Research operated for nearly two decades as Omnicare Clinical Research under the Omnicare, Inc. parent company. Dating back to the late 1990s, Omnicare Inc. acquired several smaller CROs—including Coromed and IBAH—and launched Omnicare Clinical Research in the year 2000.
Today, we have grown into a global organization with 900+ employees located throughout 27 countries. As our story continues to unfold, one factor remains constant: our people are committed to our clients and their success. For that reason, we strive to enhance our business on an ongoing basis. Whether it’s by opening a new office location, implementing a new technology, or maximizing a strategic new partnership, Theorem Clinical Research understands how to meet your evolving drug development needs.
So what makes us different? Theorem can manage even the most complex project--from study design to product launch and beyond. Our clients see us as “the right size” CRO—big enough to successfully manage your large global trials, but with a personalized service level you might associate with a smaller organization. And we execute with speed, flexibility and an attention to detail that drives high-quality performance. Additionally, we have unique strengths in Asia Pacific and Latin America.
Our comprehensive clinical service offering includes the following:
? Project Management
? Clinical Monitoring*
? Clinical Data Management*
? Regulatory Affairs*
? Clinical Quality Assurance
? Safety Surveillance/Pharmacovigilance*
? Biometrics*
? Clinical Writing
? Investigator Agreements
? Medical Affairs
? Patient Recruitment
The Theorem Clinical Research name is new. But it is built on a long history of delivering exceptional services and support for all phases of clinical research. Before launching in 2011, Theorem Clinical Research operated for nearly two decades as Omnicare Clinical Research under the Omnicare, Inc. parent company. Dating back to the late 1990s, Omnicare Inc. acquired several smaller CROs—including Coromed and IBAH—and launched Omnicare Clinical Research in the year 2000.
Today, we have grown into a global organization with 900+ employees located throughout 27 countries. As our story continues to unfold, one factor remains constant: our people are committed to our clients and their success. For that reason, we strive to enhance our business on an ongoing basis. Whether it’s by opening a new office location, implementing a new technology, or maximizing a strategic new partnership, Theorem Clinical Research understands how to meet your evolving drug development needs.