Job Information
ThermoFisher Scientific Sr Clin Data Assoc - FSP 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 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.