Job Description
Summarized Purpose: Acts as a lead data manager for one or more projects and a liaison to the Project Lead and /or client as required.
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.
- ## Provides training and work direction to junior staff as required.
Education and Experience: Bachelor's degree or equivalent and relevant formal academic / vocational qualification.
Previous experience that provides the knowledge, skills, and abilities to perform the job (6+ years)
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
- ## Positive 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
📌 Sr Clinical Data Team Lead (India)
🏢 Thermo Fisher Scientific
📍 India
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