Global Data Manager
RPS Beijing, A PRA Health Sciences Company
- 公司规模：1000-5000人
- 公司性质：外资（欧美）
- 公司行业：制药/生物工程 外包服务
职位信息
- 发布日期：2017-02-09
- 工作地点：北京
- 招聘人数：若干人
- 学历要求：本科
- 语言要求：英语
- 职位月薪：0.8-1.5万/月
- 职位类别：临床数据分析员 临床研究员
职位描述
职位描述：
This is a professional individual contributor role that provides a study level data management CRO oversight and takes data management accountability for one or more low to moderate complexity trials.Makes recommendations and influences decisions to trial processes in line with business needs and in support of Clinical Development and Medical Affaires clinical studies. Looks over DM CRO project timelines and ensures quality of DM deliverables by CRO DM. Oversees E2E processes for China MAF trials. Consults with internal clients on DM issues in trial set-up, trial conduct and database lock activities. Facilitates real-time inspection readiness of all IDS deliverables for clinical trial and works on archiving documents for trials.Participates in process, system and tool improvement initiatives within IDS and presents at investigator and monitor meetings if assigned. Works with DML to facilitate compliance with regulatory guidelines. The successful candidate for this role should have the following qualifications: Bachelor’s degree (or equivalent) in Natural Sciences, Informatics or Medical Documentation 3+ years of experience as Study Data Manager in projects and study teams, with a comparable area of responsibility as requested in this SSD Fluency in English (ability to read, write and listen) is an absolute requirement, as well as an ability to communicate effectively with others and manage your time effectively. Location: Beijing and Shanghai
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This is a professional individual contributor role that provides a study level data management CRO oversight and takes data management accountability for one or more low to moderate complexity trials.Makes recommendations and influences decisions to trial processes in line with business needs and in support of Clinical Development and Medical Affaires clinical studies. Looks over DM CRO project timelines and ensures quality of DM deliverables by CRO DM. Oversees E2E processes for China MAF trials. Consults with internal clients on DM issues in trial set-up, trial conduct and database lock activities. Facilitates real-time inspection readiness of all IDS deliverables for clinical trial and works on archiving documents for trials.Participates in process, system and tool improvement initiatives within IDS and presents at investigator and monitor meetings if assigned. Works with DML to facilitate compliance with regulatory guidelines. The successful candidate for this role should have the following qualifications: Bachelor’s degree (or equivalent) in Natural Sciences, Informatics or Medical Documentation 3+ years of experience as Study Data Manager in projects and study teams, with a comparable area of responsibility as requested in this SSD Fluency in English (ability to read, write and listen) is an absolute requirement, as well as an ability to communicate effectively with others and manage your time effectively. Location: Beijing and Shanghai
职能类别： 临床数据分析员 临床研究员
公司介绍
Headline:
Do you want to watch clinical development change, or do you want to be the one to shape it?
Sub-head:
Because we’re hoping you’re here for the latter.
Body Copy:
Who are we?
We Are PRA.
We are 11,000+ employees strong, operating in more than 85 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We are getting live saving drugs into the hands those who need them most.
Who are you?
You are a forward thinker. You are an innovator that refuses to settle. You want to push the boundaries and change not just what it means to be a Clinical Research Associate, you want to change the future. You want to learn from the best, grow your knowledge and your skill set, and you want to build your career here. You want to use the latest technology and tools in the industry to push the momentum of an already growing company forward. You want to find a balance that still lets you be, well, you. Most of all, you want to do it in a place where you’re more than an employee number. A place you love working.
Still here? Good. Because if this is you, we’d really like to meet you.
Also, we have sign on bonus opportunities up to $15,000 which are pretty cool too.
What will you be doing?
As a Clinical Research Associate (CRA), you will monitor the progress of clinical studies, either at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.
What do you need to have?
? Undergraduate degree or its international equivalent in clinical, science, or health related field from an accredited institution; a licensed healthcare professional (ie, registered nurse); or equivalent work experience required
? 18 months of clinical monitoring experience required Knowledge of ICH and local regulatory authority regulations regarding drug (PREFERRED)
? All therapeutic experience is welcome including but not limited to: Oncology, Hematology, Respiratory, Cardiovascular, Pain, CNS, Infectious Disease, Metabolism, Vaccines, Transplant and Ophthalmology
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans, and individuals with disabilities
Do you want to watch clinical development change, or do you want to be the one to shape it?
Sub-head:
Because we’re hoping you’re here for the latter.
Body Copy:
Who are we?
We Are PRA.
We are 11,000+ employees strong, operating in more than 85 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We are getting live saving drugs into the hands those who need them most.
Who are you?
You are a forward thinker. You are an innovator that refuses to settle. You want to push the boundaries and change not just what it means to be a Clinical Research Associate, you want to change the future. You want to learn from the best, grow your knowledge and your skill set, and you want to build your career here. You want to use the latest technology and tools in the industry to push the momentum of an already growing company forward. You want to find a balance that still lets you be, well, you. Most of all, you want to do it in a place where you’re more than an employee number. A place you love working.
Still here? Good. Because if this is you, we’d really like to meet you.
Also, we have sign on bonus opportunities up to $15,000 which are pretty cool too.
What will you be doing?
As a Clinical Research Associate (CRA), you will monitor the progress of clinical studies, either at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.
What do you need to have?
? Undergraduate degree or its international equivalent in clinical, science, or health related field from an accredited institution; a licensed healthcare professional (ie, registered nurse); or equivalent work experience required
? 18 months of clinical monitoring experience required Knowledge of ICH and local regulatory authority regulations regarding drug (PREFERRED)
? All therapeutic experience is welcome including but not limited to: Oncology, Hematology, Respiratory, Cardiovascular, Pain, CNS, Infectious Disease, Metabolism, Vaccines, Transplant and Ophthalmology
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans, and individuals with disabilities
联系方式
- 公司地址：上班地址：金地中心