Hyderabad, Telangana, India – office based
Additional Locations Bengaluru, Karnataka, India; SAS Nagar (Mohali), Punjab, India
Must have 6 months to 1 year of experience in Clinical data management.
Job Responsibilities:
Data Validation (cleaning)
Data Management Documents/Plans (Trial Master File)
Study Start-Up Activities and User Acceptance Testing (UAT)
Data Tracking and Entry
Project Quality Management & Compliance
Skills:
- Evidence of 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
- 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:
- Demonstrates technical aptitude with awareness/potential prior experience in Microsoft Office Products (basic computer skills).
- Basic understanding of data management processes and data validation flow (e.g. Data cleaning, DB lock)
- Basic understanding of relevant ICH-GCP Guidelines, local regulatory requirements and company SOPs and study specific procedures
- Basic knowledge of Clinical Data Management Systems (e.g. InForm, Rave, Veeva, Datalabs, ClinBase.)
- Basic understanding of Clinical Study Team roles within Data Management
- Experience in clinical research industry
- Basic knowledge of medical terminology and coding dictionaries (e.g. MedDRA & WHODRUG)
- Basic knowledge of Data Management Operational processes and tasks during study start-up, conduct and close-out
- Basic knowledge of Database set-up activities, including but not limited to Database Configuration Specifications and setup of Data Validation
Education:
- Bachelor’s degree and/or other medical qualifications or relevant industry experience.
Apply here: https://jobs.parexel.com/en/job/hyderabad/clinical-data-analyst-i/877/66337302144