Job Location: Remote
Key Accountabilities:
Data Validation (cleaning)
Data Validation (cleaning)
- Lead/Responsible for data validation (cleaning/review/reconciliation) activities during conduct and database lock (Primary CDA), e.g. query management, manual/SAS listing reviews and external vendor data reconciliation.
Data Management Documents/Plans (Trial Master File)
- Perform and/or support the setup of DM documents and ensure proper documentation as per Standard Operating Procedures, ICH/GCP Guidelines.
Study Start-Up Activities and User Acceptance Testing (UAT)
- Lead/perform user acceptance testing on clinical database setups.
- Review protocols and EDC Entry Screens if required.
- Provide input on the data management timelines and coordinate the DM operational activities during database set up.
Data Tracking and Entry
- Track and review CRFs. Support data entry where required.
Project Quality Management & Compliance
- Ensure compliance to Standard Operating Procedures, ICH/GCP Guidelines.
- Perform/Lead functional QC activities on databases and/or patient data, as per business needs.
Training
- Maintain training compliance as per Job Roles assigned, including On-the[1]Job training.
- Address training needs, as per Development Goal/s identified.
- Provide relevant on-the-job training to staff and project teams as appropriate
- Act as Mentor for other clinical data analysts.
Skills:
- Strong problem-solving skills and logical reasoning
- Commitment to first time quality, including a methodical, analytical and accurate approach to work activities (attention to detail)
- Time management and prioritization skills in order to meet objectives and timelines
- Evidence of ability to work collaboratively within a team environment
- Ability to coordinate & prioritize tasks for the team when in the Primary CDA role.
- Good interpersonal, oral and written communication skills
- Learning ability and knowledge sharing approach; swift understanding of technologies and new processes
- A flexible attitude with respect to work assignments and new learning; ability to adjust rapidly to changing technical environments
- Evidence of accountability relative to Key Accountabilities in Job Description
- Written and oral fluency in English
Knowledge and Experience:
- Strong technical aptitude with awareness/potential prior experience in Microsoft Office Products (basic computer skills).
- Good understanding of data management processes and data validation flow (e.g. Data cleaning, DB lock)
- Good understanding of relevant ICH-GCP Guidelines, local regulatory requirements and Parexel SOPs and study specific procedures
• Good knowledge of Clinical Data Management Systems (e.g. InForm, Rave, Veeva, DataLabs, ClinBase.) • Good understanding of Clinical Study Team roles within Data Management
- Experience in clinical research industry
- Good knowledge of medical terminology and coding dictionaries (e.g. MedDRA & WHODRUG)
- Good knowledge of Data Management Operational processes and tasks during study start-up, conduct and close-out
- Good knowledge of Database set-up activities, including but not limited to Database Configuration Specifications and setup of Data Validation
- Basic knowledge of SAS (programmed listings)
- Basic knowledge of Data standards (CDISC)
Education:
- Bachelor’s degree and / or other medical qualifications or relevant industry experience
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