Global Medical Consulting Services (Shanghai) Co., Ltd. is a wholly owned subsidiary of US-based Global Research Services, LLC (GRS). GRS has offices also in Langenfeld, Germany, Warsaw, Poland, and Montreal, Canada. GRS is a leader in the management of clinical research programs for the pharmaceutical, biotech, and medical device communities. The company provides a full range of consulting and clinical trial management services that include protocol design, project management, data management, clinical site monitoring, biostatistical analysis, and medical report writing.
联系地址：上海市 黄浦区 上海九江路288号宏伊国际广场1201室
电子邮箱：shanghaihr@grs-cro.com
生物统计师 Biostatistician
岗位性质： 全职
年龄要求： 不限
岗位职能： 其他
学历要求： 本科
工作地点： 上海市
工作年限要求： 二年以上
招聘人数：1 语言要求： 英语
薪水待遇： 面议
职位描述：
Biostatistician 生物统计师
Position Description:
-Performs biometrics and SAS programming activities for all clinical trials involving drugs biologics and devices, and oversees the activities of programming.
-Develops statistical section in clinical trial protocol;
-Performs sample size calculations to determine the number of patients to include in a clinical trial;
-Develops Statistical Analysis Plan with input from project team and sponsor per SOPs and WPDs;
-Performs SAS programming to generate tables, listings, figures, and statistical analyses;
-Supervises/coordinates activities of relevant consultants and contractors;
-Oversees validation and quality assurance aspects of control over SAS program content, documentation and archiving of programs;
-Ensures adherence to timelines for the biostatistical and SAS programming aspects of projects;
-Other relevant duties assigned for which the incumbent is qualified.
Requirements:
-Bachelors degree in statistics.
-Minimum one year of experience in use of statistics as applied to drug or medical device development.
-Demonstrated skills in team-building and the ability to work successfully in a team environment.
-Advanced degree (Ph.D. or M.S.) in Statistics preferred.
-Degree in mathematics or formal training is a plus
-Degree in statistics in pharmacology or formal training / experience is a plus
-Good command of English skills including reading, writing and speaking
-Demonstrated computer skills including MS Office and Internet usage.
SAS程序员 SAS Programmer
岗位性质： 全职
年龄要求： 不限
岗位职能： 其他
学历要求： 本科
工作地点： 上海市
工作年限要求： 二年以上
招聘人数：2
语言要求： 英语
薪水待遇： 面议
职位描述：
SAS Programmer SAS程序员
Position Description
-Performs all SAS programming tasks for a given clinical study or studies involving investigational or
non-investigational drugs, biologics and devices. Acts as the primary point of contact for all SAS programming activities for a given clinical study or studies.
-Develop SAS programs to build analysis datasets.
-Develops SAS programs to produce data listings and Case Report Form Tabulations as by domain or by subject displays and statistical summary tables with the support by Biostatistician.
-Represents SAS Programming at project team meetings and provides updates to project team on status of tasks.
-Communicates with Project Biostatistician, Manger of Biostatistics, Project Manager and Project Coordinator
regarding project team and/or client issues.
-Ensures adherence to all timelines associated with SAS programming.
-Communicates with client regarding SAS programming design issues.
-Other relevant duties assigned for which the incumbent is qualified.
Requirements:
-Bachelor’s degree in a scientific or technical area. An advanced scientific degree is desirable;
-Minimum 2 years of SAS or related programming experience.
-Demonstrated skills in the management and resolution of SAS programming issues.
-Demonstrated team-building skills and ability to work successfully in a team environment.
-Working experience in clinical data management preferred.
-Biostatistics or statistics, medical or healthcare related education preferred.
-Good command of English skills including reading, writing and speaking
-Demonstrated computer skills including MS Office and Internet usage.
临床研究专员Clinical Research Associate
岗位性质： 全职
年龄要求： 不限
岗位职能： 其他
学历要求： 本科
工作地点： 上海市
工作年限要求： 二年以上
招聘人数：1
语言要求： 英语
薪水待遇： 面议
职位描述：
Clinical Research Associate 临床研究专员
Position description:
- Perform clinical site monitoring and collect/manage clinical research documents, including Protocol, clinical case report
forms, Patient Informed Consent Form (ICF), Investigator Brochure and Clinical Trial Related Documents;
- Set up and archive Trial Master File (TMF);
- Review protocol and Investigator’s Brochure;
- Check protocol against CRFs and ICF;
- Translate clinical trial related documents, such as protocol, ICFs, etc. when needed
- Prepare study guide and study logs;
- Assist in preparation of protocol trailing program for investigators and study personnel;
- Communicate with Investigators and Institute Review Bord(IRB) or Ethical Committee;
- Obtain the approval letter(s) from IRB or Ethical Committee for clinical trial(s);
- Deliver clinical supplies to clinical research centers;
- Visit clinical research centers;
- Monitor clinical Trials;
- Write monitoring visit report after each visit;
- Assist in organizing and facilitating Investigators’ Meeting
- Assist in handling and report of serious adverse events (SAEs);
- Assist in processing annual safety report for ongoing clinical trials;
- Identify and solve problems in clinical trials;
Requirements:
- Medical degree or BS in healthcare-related science. MS or above welcome.
- 2 years clinical practice in Internal Medicine, especially in Cardiovascular, Oncology, and Infectious Disease.
- Minimum 2 years of CRA experience or worked as a study coordinator at study sites.
- Good command of English, including reading, writing and speaking.
- Good computer skills including MS Office, Outlook and Internet usage.
项目经理 Project Manager
岗位性质： 全职
年龄要求： 不限
岗位职能： 其他
学历要求： 本科
工作地点： 上海市
工作年限要求： 五年以上
招聘人数：1
语言要求： 英语
薪水待遇： 面议
职位描述：
Position Description:
The Project Manager (PM) leads the project team in development strategy design process and its execution for a clinical trial, optimizing metrics including risk, cost, quality, and time tradeoffs consistent with a sponsor's objectives. Monitors the project development process and ensures that key requirements and milestones are identified and met. Serves as the point-of-contact for cross-functional communication and tracking.
Travel Estimate: < 25%
Responsibilities Include:
-Develops a broad knowledge of drug/device development trends.
-Leads project team in designing and executing development plan for a project.
-Leads project team in developing common mission, goals, commitment, and standards of behavior.
-Collaborates with sponsors to ensure that all relevant scientific issues and opportunities are addressed in project plan.
-Assures that the conduct of assigned clinical research studies are completed in accordance with relevant corporate SOPs, FDA and local regulations, and GCP/ICH guidance documents.
- Manages resource constraints, risks, and conflicts, which could impact the project timeline, quality, or budget. Develops and implements plans to minimize their impact.
- Manages cross functional groups to ensure effective communication, and on-time, on-budget completion of contracted tasks.
-Coordinates the management of all financial aspects of the clinical trial with other project team members, including budget expenditures and change orders.
-Reviews original budget tracker for compliance with scope of work and then maintaining the budget tracker on a monthly basis.
-Participates in proposal development and in investigator and sales presentations.
-Documents project team's activities accurately through minutes, plans, and recommendations.
-Manages the project team to complete all contracted tasks, including activities associated with third-party vendors and internal functional groups.
-Other relevant duties assigned for which the incumbent is qualified.
Requirements include:
-Medical degree and two years of experience in the management of clinical projects or equivalent education and experience.
-Demonstrated ability to manage budgets and personnel.
-Demonstrated ability to work successfully in a team environment requiring matrix management.
-Demonstrated ability to evaluate and critique scientific reports and literature relative to drug and device development.
-Demonstrated knowledge of FDA regulations and requirements governing the conduct of clinical trials including GCP and ICH.
-Demonstrated ability to make effective presentations in public settings.
-Demonstrated ability to interact with clients on sensitive issues and handle concerns appropriately.
-Experience with team building and conflict resolution desirable.
-Demonstrated skills in oral and written communication in both Chinese and English.
-Demonstrated computer skills including MS Office and Internet usage. |
