Sr Clin Data Assoc

Pharmaceutical Product Development (PPD)

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. 

  • 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 & 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  Proven ability in achieving applicable technical competencies per the DM competency gri

Job posted: 2024-04-22