智联提示您：用人单位以任何名义向应聘者收取费用都属违法行为（如押金、资料费、代收体检费、代收淘宝信誉等），请提高警惕并注意保护个人信息！
您当前所在位置&&&当前页面
Project Data Manager
年底双薪交通补助餐补房补通讯补贴采暖补贴带薪年假弹性工作
职位月薪：面议
工作地点：
发布日期：
工作性质：全职
工作经验：5-10年
最低学历：不限
招聘人数：1人
职位类别：
Essential Functions:&1. & & & Acts as Project Leader on a stand alone contract (&project&) for
Data Management, to include:a. & & & primary customer contact for all contracted Data Mb. & & & direct liaison with Finance and Contract department on required
matters (e.g., invoicing, contract changes).2. & & & Acts as Functional Lead for Data Management on full service
contracts to include:a. & & & primary contact for internal liaison between Data Management and
Company Project Management, Clinical Monitoring, and other functional groups on
'full service'b. & & & liaison with Finance and Contracts groups via the Project Leader
(e.g., concerning invoicing, contract changes).3. & & & Ensures launch, delivery and completion of all Data Management
according to contractual agreement and relevant Standard Operating Procedures
(SOPs), guidelines, and regulations.4. & & & Manages changes of scope, budget, revenue recognition, and
participation in monthly internal project reviews.5. & & & Monitors and communicates project progress to the customer and
project team including use of project status reports and tracking
tools/metrics.6. & & & Plans, manages, and requests resource as required for assigned
studies.7. & & & Maintains a consistent, manageable workflow for Data Management
project team by monitoring enrollment information and communicating with project
team to actively influence data collection.8. & & & Develops and maintains:a. & & & Data Management Pb. & & & Project Management Plans (for stand-alone contracts only);c. & & & &Communication Plans (for stand-alone contracts only);d. & & & SAE Reconciliation Ge. & & & &Quality P and other plans as delegated/required.9. & & & Assists in the negotiation and contracting process with outside
vendors such as e-CRF/Diary vendors, CRF Printer, and IVRS vendors.10. & &Maintains documentation on an ongoing basis and ensures that all
filing is up to date.11. & &Regularly reviews project files to ensure that all filing is up to
date.12. & &Manages the database freeze and lock processes and procedures.13. & &Ensures that all applicable documents and databases (data sets) are
archived or returned to the customer appropriately.14. & &Coordinates user testing per User Test Plans developed for data
entry screens, electronic edit checks, data listings, import/export programs,
and medical coding.15. & &Provides project specific training for:a. & & & CRAs to be able to train site staff to use EDCb. & & & site staff to use EDCc. & & & &project team in project specific requirements.16. & &Manages Quality Control (QC) process for checks of CRF database
versus Case Report Forms (CRFs) and Data Clarification Forms (DCFs):a. & & & specifies required CRFb. & & & summarizes results and resolves issues from checks of such
listings against CRFs and DCFs.17. & &Schedules and requests data transfers/imports/exports to/from
CRF/eCRF database and associated databases.18. & &Reviews and approves:a. & & & project plans and guidelines for data validation, electronic data
interchange, coding, CRF/eCRF screen, database design, user testing, CRF
tracking, CRF/eCRF completion and other applicable project plans as
delegated/b. & & & specifications for listings and summaries (other than for
statistical reporting requirements) from CRF databases, and external data
c. & & & &output from listings and summaries (other than for statistical
reporting requirements) from CRF databases, and external data sources.19. & &Participates in, and presents at internal, customer, third-party,
and investigator meetings.20. & &Plans for and creates necessary documentation to support internal
participates in such audits.21. & &Participates in the development of departmental technologies, SOPs,
processes, and procedures.22. & &Develops and delivers applicable data management departmental
training.23. & &Trains and mentors data management staff.24. & &Contributes to the Request for Proposal (RFP) and Request for
Information (RFI) process. &Prepares input for, and participates in proposal bid
defense meetings.Maintains proficiency in Data Management systems and processes through
regular training. &Takes the opportunity to network with colleagues for new
and/or repeat business.&&Other Responsibilities:&Perform other work-related duties as assigned. &Minimal travel may be
required (up to 25%).Requirements:BA/BS in the biological sciences or related disciplines in the natural
science/health care field. &Moderate clinical data management experience or an
equivalent combination of education and experience. &Experience Clinical Data
Management practices and relational database management software systems.
Demonstrated staff leadership skills. &Contract Research Organization (CRO)
experience preferred. &Direct exposure to Oracle Clinical, Rave, or Inform
systems. &Knowledge of &medical terminology, clinical data, and ICH/Good
Clinical Practices. &Proficiency in MS Windows navigation, Word, Excel,
PowerPoint, and email applications. &Effective oral and written communication
skills. &Good organizational, planning, and time management skills with the
ability to multitask under tight deadlines while providing attention to detail. &
Ability to be flexible and adapt to change, to work independently, as well as
part of a multi-disciplinary team. &Ability to make effective decisions and
manage multiple priorities in a highly dynamic environment.&
工作地址：
北京市朝阳区建国门外大街2号银泰中心C座5层
最新职位推荐
今日相似推荐
地点：北京地点：北京地点：北京地点：北京地点：北京地点：北京地点：北京地点：北京地点：北京地点：北京
地点：北京地点：北京地点：北京地点：北京地点：北京地点：北京地点：北京地点：北京地点：北京地点：北京
公司规模：100-499人
公司性质：外商独资
公司行业：
公司主页：
公司地址：
北京市朝阳区建国门外大街2号银泰中心C座5层
您也许对以下职位类别感兴趣:
热门职位推荐:Discover our excellent products & Put your trust in the care we provide.
Chang Gung Medical Technology Co., Ltd. (CGM) is a business expansion of Chang Gung Medical Foundation as well as a relative enterprise to Formosa Plastics Group. In 2007, CGM Started expanding from high-end hospital equipments into the field of Medical Imaging and Physiological Monitoring System.
Therefore, nowadays CGM has been specializing in hospital equipments, such as Hospital Beds, Stretchers, Pediatric Beds, E-carts, Medication Carts, Ward Furniture and etc.. Also CGM product lines have been stretching into medical diagnostic and monitoring devices, such as Doppler Ultrasound System, Non-Invasive Blood Pressure Monitor, POCT Blood Glucose Monitoring system, Dental Implant and so on.
With our group of well-established enterprise resources and medical background, it leads CGM to an outstanding and responsible manufacturer as well as a service provider...
Chang Gung Medical Technology Co., Ltd.
11F., No.201-4, Dunhwa N. Rd., Songshan Dist., Taipei City 105, Taiwan (R.O.C.)
Tel： +886 - 2 -
Fax：+886 - 2 -}