POSITION SUMMARY:

Assists in testing of databases and maintenance of study data, including the processing of discrepancies and queries. Assists in reviewing CRFs, data listings and database to ensure that all captured data follow the rules outlined by the protocol and data management plan.

RESPONSIBILITIES:

• Assists in maintaining databases and performing database updates

• Reviews CRFs, data listings and database to ensure that all captured data follow the rules outlined by the protocol, data management plan, and other data management documents

• Generates paper and electronic queries to appropriate internal or external personnel (investigational sites, vendors, Clinical Research Associates, client representatives) to resolve problematic data identified during every aspect of the data management process

• Reviews responses to queries for appropriateness, resolves any discrepancies and ensures that the database is modified accordingly

• Tracks CRFs

• Reconciles external data from other vendors

• All other projects as assigned

  
  Other

• Quality control reviews output of the clinical database (entry screens or data listings) against primary documents (e.g., data management plan, case report forms and queries) for data accuracy, consistency and application of predetermined conventions

• Assists in writing quality control reports in a timely and concise manner according to standard operating procedures

  
  EDUCATION, SKILLS & COMPETENCIES:

• Educational Background

• Educated to Bachelor’s degree level, or equivalent. In lieu of this qualification, 1 year of experience in clinical research, drug development or healthcare environment will be required

• Experience

• Understanding and experience with up to date MS Windows Operating Systems and applications

• Working knowledge of medical terminology and experience with clinical research preferred

• Expertise and know-how

• Attention to detail and able to independently resolve a variety of issues without close supervision

• Personal skills & behaviours

• Fluent verbal and written English as well as the local language(s) required for clinical trial submissions.

• Excellent team player, collaborative and able to build an effective team.

• Ability to multitask and work effectively in a fast-paced environment with changing priorities.

• Strong verbal and written communication and negotiation skills.

• Excellent organizational and time-management skills, able prioritize work to meet deadlines.

• Accountable, dependable and strong commitment.

• Is customer service focused in approach to work both internally and externally.

• Maintains a positive, results orientated work environment.

The above job description is intended to describe the key responsibilities but is not an exhaustive summary of all responsibilities, duties and skills that are required. The company reserves the right to vary the job descriptions as per their requirements.

上班地址：上海张江哈雷路866号