Clinical Data Associate Ii - Remote

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.

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Clinical Data Associate Ii - Remote

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:

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