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Clinical Data Associate Ii - Remote

Thermo Fisher Scientific
Thermo Fisher Scientific
0-5 years
Not Disclosed
12 April 22, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm Skills: Causality Assessment, Communication Skills, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Description

 

Summarized Purpose: 
Performs advanced aspects of the data cleaning process with a high level of accuracy and in accordance with GCPs and SOPs/WPDs, to assess the safety and efficacy of investigational products and/or medical devices. 

 

Essential Function:

 Identifies, resolves, and updates data discrepancies. Makes changes to the data management database as required. 
 Generates, tracks and resolves data clarifications and queries. May implement 
CRF design in identified graphic design package. 
 Reviews data listings for accuracy and consistency of data. Analyzes and 
resolves data validation and other data management reports. 
 Produces project-specific status reports for CDM management and for clients on a regular basis. 
 Performs data management activities such as Serious Adverse Event and Third 
Party Vendor reconciliations as well as Data Listing reviews. 

 

Knowledge, Skills and Abilities: 
 Applies knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, global SOPs and client expectations 
 Strong attention to detail and skill with numbers and ability to use interactive computer programs 
 Good written and verbal communication skills and a strong command of English language and grammar 
 Good organizational and analytical/problem-solving skills 
 Ability to work productively with moderate supervision 
 Ability to maintain a high degree of confidentiality with clinical data and client's proprietary data 
 Strong customer focus and excellent interpersonal skills.