Job Information
ThermoFisher Scientific Sr Clin Data Assoc in Remote, India
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 Function:
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.
Provides training and work direction to junior staff as required
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.
Knowledge of medical/clinical terminology
Understands project protocol and DVM
Proven ability in achieving applicable technical competencies per the DM competency grid
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.