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