临床项目助理 CTC - Core/FSP
百时益医药研发(北京)有限公司
- 公司规模:150-500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:2022-06-27
- 工作地点:北京-东城区
- 工作经验:1年经验
- 学历要求:本科
- 职位月薪:7千-1.2万·13薪
- 职位类别:临床协调员
职位描述
PPD is now part of Thermo Fisher Scientific. We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health.
At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.
The basic purpose of the CTC is to provide technical support to the project team. Will coordinate non-clinical responsibilities of project administration as applicable to the client contract under the direction of the assigned Clinical Manager or Sr. Clinical Manager.
Essential Functions and Other Job Information:
Coordinates, oversees and completes administrative functions on assigned trials including, but not limited to, reviewing and transmitting regulatory documents, processing documents sent to file, QC and reconciling project reports, performing mass mailings and faxes, managing and distributing paper study supplies to sites.
Performs PPD Investigator file reviews and logs findings in CTMS.
Maintains assigned data points within CTMS according to the established conventions within specified times.
Coordinates team conference calls, documents, completes and distributes meeting minutes from internal/client meetings.
Education and Experience:
Bachelor’s Degree preferred or good general education, combined with evidenced administrative competence and relevant IT skills. In all cases, the combination of education, training and experience provides the individual with the required knowledge, skills and abilities to do the job. General administrative experience preferrably in clinical research administration.
Knowledge, Skills and Abilities:
Self-motivated, positive attitude with effective oral and written communication and interpersonal skills
Ability to work in a team or independently, as required
Good organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively
Demonstrated ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
Strong customer focus
Flexibility to reprioritize workload to meet changing project timelines
Demonstrated ability to attain and maintain a good working knowledge of applicable FDA
Regulations, ICH Good Clinical Practices, and PPD/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeout.
Strong English language and grammar skills
Strong computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems
Ability to successfully complete PPD clinical training program
PPD is now part of Thermo Fisher Scientific.
Our Mission
· We enable our customers to make the world healthier, cleaner, and safer.
Our 4i Values
· Integrity - Honor commitments, communicate openly, and demonstrate the highest ethical standards
· Innovation - Create value by transforming knowledge and ideas into differentiated products and services for our customers
· Intensity - Be determined to deliver results with speed, excellence and a passion to succeed
· Involvement - Make connections to work as one global team, embracing unique perspectives and treating others with dignity and respect
?
If you resonate with our 4i Values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.
At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.
The basic purpose of the CTC is to provide technical support to the project team. Will coordinate non-clinical responsibilities of project administration as applicable to the client contract under the direction of the assigned Clinical Manager or Sr. Clinical Manager.
Essential Functions and Other Job Information:
Coordinates, oversees and completes administrative functions on assigned trials including, but not limited to, reviewing and transmitting regulatory documents, processing documents sent to file, QC and reconciling project reports, performing mass mailings and faxes, managing and distributing paper study supplies to sites.
Performs PPD Investigator file reviews and logs findings in CTMS.
Maintains assigned data points within CTMS according to the established conventions within specified times.
Coordinates team conference calls, documents, completes and distributes meeting minutes from internal/client meetings.
Education and Experience:
Bachelor’s Degree preferred or good general education, combined with evidenced administrative competence and relevant IT skills. In all cases, the combination of education, training and experience provides the individual with the required knowledge, skills and abilities to do the job. General administrative experience preferrably in clinical research administration.
Knowledge, Skills and Abilities:
Self-motivated, positive attitude with effective oral and written communication and interpersonal skills
Ability to work in a team or independently, as required
Good organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively
Demonstrated ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
Strong customer focus
Flexibility to reprioritize workload to meet changing project timelines
Demonstrated ability to attain and maintain a good working knowledge of applicable FDA
Regulations, ICH Good Clinical Practices, and PPD/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeout.
Strong English language and grammar skills
Strong computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems
Ability to successfully complete PPD clinical training program
PPD is now part of Thermo Fisher Scientific.
Our Mission
· We enable our customers to make the world healthier, cleaner, and safer.
Our 4i Values
· Integrity - Honor commitments, communicate openly, and demonstrate the highest ethical standards
· Innovation - Create value by transforming knowledge and ideas into differentiated products and services for our customers
· Intensity - Be determined to deliver results with speed, excellence and a passion to succeed
· Involvement - Make connections to work as one global team, embracing unique perspectives and treating others with dignity and respect
?
If you resonate with our 4i Values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.
公司介绍
PPD是一家全球领先的医药研发外包服务公司(CRO),提供全面的综合药物研发,实验室与生命周期管理服务。我们的客户及合作伙伴包括制药,生物技术,医疗器械,学术机构以及政府组织等。PPD在全球46个国家设有办事处,拥有超过24,000名专业员工。PPD借助创新的前沿技术,专业的治疗技能以及坚定的质量承诺,帮助客户及合作伙伴降低药物开发的成本和时间,研制创新、有效和安全的医疗产品,为改善人类健康作出更大的贡献。
联系方式
- 公司地址:东直门南大街1号来福士大厦