Location
India | India
Job description
Clinical Data Analyst is a safety professional responsible for assessing and entering all the subject related information into Electronic Data Capture Systems in clinical trials. Using standard guidelines, they capture, review and enter all subject related data into given EDC systems.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Analyzes, reviews, and interprets subject data from clinical trials and enters them into EDC systems
- Perform data entry for all subject information into EDC databases as required
- Perform peer review, quality review of all EDC data entered as required
- Accountable for sending queries for clarity associated with incoming information if required
- Contributes to safety and pharmacovigilance training programs.
- Collaborates with Regulatory Affairs to ensure appropriate reporting of pharmacovigilance and drug safety information to regulatory agencies and prescriber community.
- Administer Sitero Mentor Event Reporting system if needed
- Participate in team calls and provide updates on issues noted at study sites
EDUCATION AND EXPERIENCE REQUIRED:
- Minimum 2+ year of experience of working in clinical trial domain
- Degree in Life Science/Pharma or Equivalents
PREFERRED SKILLS:
- 2+ year of experience in clinical research domain
- Awareness of GCP, GDPR HIPAA regulations
- In depth Knowledge and understanding of clinical trials and its phases
- Strong organizational, documentation, and interpersonal skills essential to interact with clients, management, peers and cross functional teams effectively.
- Good working knowledge of US and EU drug safety regulations, CIOMS and ICH guidelines.
- Excellent verbal, written and presentation skills.
- Innovative, collaborative, initiative-taker.
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