Job Description

Summarized Purpose:

Performs all aspects of the data cleaning process, with minimal supervision, in accordance with GCP and SOPs/WPDs in order to assess the safety and efficacy of investigational products and/or medical devices.

Essential Functions:

Supports the setup of study activities such as database design, testing of data

entry screens, and Data Validation Manual (DVM) creation, as required.

Reviews data listings for accuracy and consistency of data.

Acts as point person and subject matter expert for specialized study-specific processes.

Generates, tracks and resolves data clarifications and queries and makes changes to the clinical database as required.

Contributes to the improvement of data management processes on a global level.

Produces project-specific status reports for management and/or clients on a regular basis.

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

Good written and verbal communication skills

Good analytical/problem-solving skills

Ability to maintain a high degree of confidentiality with clinical data and client's proprietary data

Strong customer focus and excellent interpersonal skills.

Proven flexibility and adaptability

Must be able to set and meet timelines or be able to negotiate schedule changes in response to project demands

Knowledge of medical/clinical terminology

Understands project protocol and DVM

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.