- ental audits and regulatory compliance activities.
- Develop and maintain clinical data management reports.
- Develop and review programs and databases used to manage clinical trial data.
- Respond to EDC help desk requests.
- Provide support for project management requests and other assigned data management activities.
Qualification & Eligibility
Candidates interested in the Biorasi Clinical Data Management job in Mumbai should meet the following requirements:
- Bachelor’s degree or equivalent qualification.
- A degree in a scientific or IT-related discipline is preferred.
- Advanced degree or diploma is preferred but not mandatory.
- 1–3 years of prior Data Management experience, or successful completion of at least one year in an Associate 1, Data Management position or equivalent.
- Knowledge of FDA, ICH and Good Clinical Practice (GCP) guidelines.
- Good computer literacy and proficiency in Microsoft Office.
- Fluent written and spoken English.
- Excellent organizational and communication skills.
- Strong attention to detail.
Experience Required
Applicants should have 1 to 3 years of prior Clinical Data Management experience.
Candidates may also qualify if they have successfully completed at least one year as Associate 1, Data Management or an equivalent role.
This vacancy is therefore primarily suitable for early-career Clinical Data Management professionals rather than complete freshers without relevant CDM experience.
Key Skills
Clinical Data Management (CDM), Electronic Data Capture (EDC), clinical data cleaning, EDC query management, query resolution, database design, database setup, User Acceptance Testing (UAT), CRF Completion Guidelines, data validation, vendor data reconciliation, database lock, TMF activities, 21 CFR Part 11, FDA guidelines, ICH guidelines, GCP and clinical trial data management.
Employee Benefits
According to Biorasi, employees receive a range of benefits designed to support professional development and well-being, including:
- Half-day Fridays
- Paid time off
- Paid holidays
- Country-specific employee benefits
- Employee bonus programs
- Career growth opportunities
- Training and professional development
Specific benefits may vary according to employment terms and local policies.
How to Apply
