This inclusive employer is a member of myGwork the largest global platform for the LGBTQ+ business community.
Work Schedule
Other
Environmental Conditions
Office
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
