Sr Clinical Data Associate

2 weeks ago


Pune, Maharashtra, India Lifelancer Full time

About the job

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

Please use the below link for job application and quicker response.



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