Associate Clinical Trial Manager(ACTM)
RPS医药科技(北京)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:2019-04-12
- 工作地点:北京
- 招聘人数:若干人
- 工作经验:5-7年经验
- 学历要求:本科
- 职位月薪:25-35万/年
- 职位类别:临床研究员
职位描述
Responsibilities:
- Confirms all site related activities and files are completed per the SOPs. The employee is a key point of contact for study specific questions from both internal (eg, site monitors, clinical services specialist) and external (eg, site personnel, vendors) customers. They facilitate communication across departments and elevate site and study issues as appropriate.
- Reviews clinical data through various sources in order to monitor overall clinical data quality and identify and resolve potential study or site issues as appropriate. They perform quality checks of all study plans (eg, monitoring plan) and study reports. They review and code protocol deviations.
- Sets-up, tests, reviews, and updates clinical systems (eg, CTMS) and tracking tools. They are responsible for collecting and tracking study specific data and producing clinical status, trend, and metric reports to assist the manager in proactive study management and contingency planning.
- Responsible for the logistical tasks associated with the preparation, collection, review and tracking of the master and site non-regulatory file documents. They will verify the accuracy and completeness of all study files prior to final archival.
- Responsible for completing all required training to execute their job and maintain training records. They are responsible for reporting any potential GCP violations either internally or externally to their manager and participate in any corrective and preventative action plans as appropriate. They are responsible for reporting any safety concerns to the appropriate department including but not limited to Serious Adverse Events. In addition, the employee is responsible for documenting key communications from either internal or external sources in the study file.
- Responsible for adherence to all relevant regulations including ICH, PhRMA and CFR guidelines, as well as Client’s policies, SOPs and Work Instructions. Ongoing training in compliance areas and therapeutic specific knowledge is expected in order to maintain a solid knowledge base for performing assigned tasks.
Qualifications:
- Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required
公司介绍
RPS Inc. is a next generation global CRO, headquartered in the United States with the operations in 45 countries throughout Americas (US, Canada, Latin America), EMEA and Asia Pacific regions. RPS provides comprehensive global Phase 1-4 clinical development solutions to the pharmaceutical, biotechnology and medical device industries. By combining an experienced clinical research operations infrastructure with the industry’s largest resourcing engines, RPS is uniquely positioned to offer our Clients both integrated and full service global outsourcing solutions. These solutions are powered by highly experienced and seasoned study teams providing innovative, cost-effective and high quality services.
RPS Asia Pacific Headquarters is located in Beijing, China and we have operations in 11 Countries in Asia Pacific region. With the rapid organic expansion of RPS in China & Asia Pacific, we are continuously looking for the experienced industry talents to join us.
Our specialized staff of consultants is eager to discuss your career plans. Tell us about yourself experience, so the appropriate consultant can contact you. RPS is sensitive to your daily responsibilities. Tell us EXACTLY how to contact you and we will. For your convenience, you can also submit your resume. We look forward to discussing the opportunities and benefits of employment with RPS!
For more information, please visit our website www.rpsweb.com.
RPS Asia Pacific Headquarters is located in Beijing, China and we have operations in 11 Countries in Asia Pacific region. With the rapid organic expansion of RPS in China & Asia Pacific, we are continuously looking for the experienced industry talents to join us.
Our specialized staff of consultants is eager to discuss your career plans. Tell us about yourself experience, so the appropriate consultant can contact you. RPS is sensitive to your daily responsibilities. Tell us EXACTLY how to contact you and we will. For your convenience, you can also submit your resume. We look forward to discussing the opportunities and benefits of employment with RPS!
For more information, please visit our website www.rpsweb.com.
联系方式
- Email:haoallen@prahs.com
- 公司地址:地址:span西藏中路268号来福士广场