職位描述
職位描述：
The role of the Clinical Data Analyst (CDA) is to perform all clinical data cleaning activities on
assigned projects, commensurate with experience and/or project role. Key activities include data
validation, generation and integration of queries, coding of clinical data, reconciliation of safety and
electronic data.
The Clinical Data Analyst will assume the Clinical Data Manager responsibilities on studies that started
Key Accountabilities
？？Utilize current study documentation including protocol, Case Report Forms (CRFs), Cleaning
guidelines etc.
？？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
？？Track and integrate queries
？？Perform clinical coding if appropriate to role within the project team
？？Ensure all documents coded for submission to central files
？？Lock site(s) within EDC system - remove user's data modification privileges
？？Interact with site (via mail) as required
？？Perform early and final database QC activities
？？Update all relevant tracking system on an ongoing basis
？？Inform responsible CDA coordinator of work status regularly
？？Keep manager informed about work progress and any issues to avoid surprises. Requires
regular interaction / supervision by Manager or assigned mentor
？？Maintain a working knowledge and ensure compliance with applicable ICH-GCP Guidelines,
local regulatory requirements and PAREXEL WSOP and stud specific procedure
？？Complete routine administrative tasks in a timely manner (e.g. timesheets, metrics, travel
expense claims
Skills
？？Good computer skills including but not limited to the knowledge of Clinical Trial/Data
Management Systems, PMED, MS-Office products such as Excel, Word.
？？Demonstrate a sound awareness of all relevant regulations, including GCP
？？Ability to successfully work in a (‘virtual’) team environment
？？Client focused approach to work
？？If required, knowledge of medical terminology and awareness of coding dictionaries (e.g.
MedDRA & WHODRUG)
？？Solid interpersonal, verbal and written communication skills
？？Sense of urgency in completing assigned tasks
？？Meticulous attention to detail
？？Effective time management in order to meet daily metrics or team objectives
？？Shows commitment to and performs consistently high quality work
Education
？？Bachelor’s degree and / or other medical qualification or relevant DM experience
Language Skills
？？Competent in written and oral English
