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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.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.