職位描述
崗位職責： Prepare Data Cleaning Specification
? Review Specification documents prepared by GTS
? Participate in internal configuration review meeting for database set-up
? Initiate the running of study specific programs
? Conduct in-house data review,
? Generate and close queries or apply self evident corrections to the data according to the relevant guidelines
? Identify and report protocol violations
? Manual and Patient Profile review, issue queries
? Conduct reconciliation of SAEs, send out queries as required and notify relevant Safety Groups of possible issues for their action
? Perform clinical coding
? Liaise with 3rd party vendors to clean electronic data
? Ensure all documents coded for submission to central files
? Lock site(s) within EDC system - remove user's data modification privileges or access
? Interact with site (via mail) as required
? Perform early and final database QC activities
? Update all relevant tracking system on an ongoing basis任職要求：Strong computer and internet skills including knowledge of MSFT products such as Excel, Word.
? Strong regulatory knowledge including GCP
? Sound oral and written communication skills
? Sound problem solving skills
? Ability to successfully work in a team environment
? Strong customer focus both internally and externally
? Ability to prioritize multiple tasks and achieve project timelines
? Knowledge of medical terminology and awareness of coding dictionaries (e.g. MedDRA & WHODRUG)
? Solid interpersonal, verbal and written communication skills
? Able to take initiative and work independently
? Sense of urgency in completing assigned tasks
Education
? Bachelor’s degree and / or other medical qualification or relevant DM experience.
Language Skills
? Ability to speak and read the language(s) used locally in the country, plus a fluency in written and spoken English.
Minimum Work Experience
? Relevant work experience .
