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Data Manager

Job overview

Responsible for clinical trial data management related work, draft data management plan and related documents according to the requirement of the project.

Job Responsibilities

Responsible for the delivery of clinical trial data management of the project, including but not limited to:

1. (e) Design of the CRF;

2. (e) Drafting and training of CRF entry rules;

3. Drafting of data validation plan;

4. Database construction: (e) CRF construction, construction of dynamic rule and logic verification, custom report programming, data migration, test         script generation, database release, system docking support, etc.;

5. Data management system and related system account management and cleaning;

6. Data reception and entry (if applicable);

7. Data cleaning: Question management based on the frequency specified by the project, offline data verification, external data cleaning, etc.

8. Medical coding: use standard dictionaries to carry out medical coding work for medical terms and drug names, and solve related data issues in the

   process;

9. According to the change of the test plan and project requirements, update the database and related documents, etc.;

10. Data blind audit;

11. Database locking and data transmission and storage, etc.;

12. Quality control of data management and solution of issues;

13. Data privacy and subject personal information protection.

Job Requirements

1. Bachelor degree or above (Medicine, Pharmacy related majors);

2. Knowledge of clinical data management applications (clinical data management systems, query tools, MS Office suite). Have experience in using

   clinical data management system; have a certain understanding of data management and statistical analysis tools (such as SAS, SQL, Excel, etc.);

3. Understand the basic concepts, processes and related standards of clinical data management;

4. Familiar with the requirements of GCP, and understand the regulations and requirements of regulatory authorities such as NMPA/EMEA/FDA;

5. Good English listening, speaking, reading and writing skills.

Statistical Programmer

Job overview

Use statistical programming knowledge to carry out relevant data statistical work such as data integration, model analysis and research, and provide programming support for other data departments in the company.

Job Responsibilities

1. Write SAS programs to establish statistical data lists, statistical tables, and generate statistical reports;

2. Provide programming support for data managers and verify data by programming;

3. Write SAS programs to generate data table model SDTM (case report form data table for clinical research projects, used for content standards submitted to  

   regulatory authorities) / analysis data model ADaM (relevant analysis datasets and related documents, content standards for the submission to regulatory  

   authorities);

4. The company's internal dual programming, programming QC;

5. Understand the scheme, SAP, and give appropriate advice when necessary.

Job Requirements

1. Bachelor degree or above;

2. Majors in Medicine, Pharmacy, Public health, Biostatistics, Bioinformatics, Computer Science, etc.;

3. Basic statistical programming knowledge, such as BaseSAS, SASSTAT and SAS macro language;

4. Familiar with CDISC standards.

Biostatistician

Job overview

Independently supporting relatively basic statistical work for clinical trials. Responsible for daily review/writing of clinical protocols and validation of trial design, participation in CRF and database design, preparation of explanatory documents and tables for data analysis, and cross check output through SAS software.

Job Responsibilities

一. Clinical trial protocol design (assist investigators and sponsors to improve protocol design)

1. Blind and randomized design implementation (to guide the standardized operation of multi-center (e.g. double-blinded) clinical trials);

2. Verify the sample size calculation;

3. Review the medical record report form (CRF) and database design;

4. Write the statistical analysis part of the protocol;

5. Plan and take charge of data review meetings;

6. Draft statistical analysis plan;

7. Assist the principal investigator to improve the clinical trial design report.

二. Programming

1. Prepare documentation for analysis of databases and tables;

2. Execute SAS to audit data, verify algorithms and output results;

3. Generate and review the outputted tables/graphs.

Job Requirements

1. Master degree or above in Preventive Medicine, Epidemiology and Health Statistics, Mathematics, and Statistics, relevant work experience is preferred;

2. Familiar with SAS software and mathematical statistics methods;

3. Good English listening, speaking, reading, and writing skills.

Recruitment City

Beijing, Shanghai, Shijiazhuang, Chengdu, Wuhan, Hainan,

Hong Kong, US

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Contact e-mail:contact@medataccess.com

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                           Zhubang 2000 BusinessCenter,
                           No. 100 Balizhuangxili, Chaoyang District,Beijing
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