天津招聘

职位描述：
The Senior Data Manager provides expertise to the Data Management deliverables of medical affairs studies
and real world evidence (RWE). He/she provides direction and oversight to outsourcing partners/providers
and ensures that data management meets all AstraZeneca requirements and those for GCP and SOPs.

ROLE & RESPONSIBILITES
？ Input to the production of the DM Service Order and costs for outsourced medical affairs studies and
RWE programs
？ Review and coordinate design/finalization of CRF/eCRF and CRF/eCRF completion instructions as
well as real world data registry systems
？ Provide direction and guidance to outsourcing partners/providers, review DM documentation and
specifications as needed to ensure consistency with AZ strategies and standards. He/she holds
partners and providers accountable for the quality of their deliverable
？ Negotiate time frames for the completion of tasks
？ Network with colleagues and experts, providing DM expertise and serving as a resource for others by
sharing experience within and beyond project team
？ Adhere to internal standard processes and comply with regulatory and compliance requirements


Job requirements
- Academic / Professional qualification
？ BSc degree essential and MS/MSc desirable in information science, biomedical/life science, statistics,
public health, computer science or related discipline
- Technical / skill training
？ Knowledge in regulatory requirements
？ Rich experience in drug development and clinical trials
？ Comprehensive knowledge of CDASH/SDTM/ADaM CDISC standards and metadata management
？ Skills for CRF/eCRF design
？ Knowledge of IVRS/IWRS and EDC systems
？ Knowledge of Oracle Basic (or other database)
？ SAS programming skills
？ Negotiation skills
- Working experience
Essential
？ Five years industrial experience at multinational pharmaceutical company or CRO
？ Cross-function experience in drug development, particularly CRF/eCRF design and DM
Desirable
？ Knowledge of observational studies and/or real world data
- Language ability
？ Excellent written and verbal communication skills in English and Chinese
- Computer literacy
？ PC/Windows application 举报 分享

  Beijing Health Tech Medical Group (HT-Med) was founded since 2004. We are a comprehensive medical Operation and development organization .Assemble excellent talents of medicine, pharmacy, data management and statistical fields, offering professional services to support biotech and pharmaceutical companies at every stage of product lifecycle .
 
 We provide Medical translation, Data Management, Statistical Analysis, Medical Writing, Regulatory Affairs, Project Evaluation and Management, Independent Audit, Training, CRA/CRC/DM dispatch. Since we established, we were developing new drugs with Chinese Academy of Medical Sciences, Peking University Health Science Center, The General Hospital of the PLA, Military Medical Sciences, etc. Has cooperated with over 90% clinical trial sites (hospital) approved by SFDA.

  We developed independently EDC+CTMS by ourselves, obtained 3 patents and 2 brands. Basing on excellent IT capability, we develop Products Data Center for our clients, and created role exchange pattern between CRA and CRC, improved speed&quality of Clinical Study by the model of EDC+CRC, especially in PMS. We have been became the vendor of lots of global company (AZ, GSK, BI, Abbott, Roch, Mundipharma, QPS etc.) and some official Institution (Chinese Academy of Medical Sciences, Peking university, The general hospital of Chinese PLA, Sanming hospital, Zhejiang oncology hospital, Academy of Military Medical Sciences of the Chinese PLA etc.).

 We are familiar with China SFDA policy and CDE mentality, possessing mass of expert resource and marketing support. we could cover 90% Chinese certificated clinical research hospital by lots of home-based employee in 18 cities.

  公司邮箱：ling.zhang@ht-med.com
  公司网址：http://www.ht-med.com