Senior Associate, Data Management
About the Role
Company Description
Biorasi is an award-winning customer-focused, service clinical research organization that loves to use new ideas and work well with others. Biorasi makes sure people can grow in their jobs by looking at what each person's good at and helping people keep a good balance, between work and home life. Biorasi welcomes people who have worked in research for a long time and people who are just starting out. Biorasi gives everyone a chance to help with trial activities and help make new medicines while growing inside the global clinical research industry.
Job Summary
The Data Management professional will manage trial data activities by maintaining EDC systems handling queries performing data cleaning and conducting database validation and UAT. The role will also support data reconciliation and database lock activities prepare data management documents and reports maintain study documentation and TMF records assist with audits and address system-related requests while ensuring compliance with research regulations and quality standards.
Key Responsibilities
Perform data cleaning. Monitor the issuance and resolution of EDC queries.
Develop Data Management Plans, Data Validation Plans and System Validation Plans.
Manage user access to study systems while ensuring compliance with 21 CFR Part 11 requirements.
Conduct vendor data reconciliation to maintain data accuracy and consistency.
Support EDC database design, setup, administration and maintenance, under supervision.
Develop database validation specifications and CRF Completion Guidelines.
Prepare UAT scripts and conduct User Acceptance Testing for study databases.
Collect, maintain and archive clinical study documents and TMF records.
Support database lock activities. Prepare study reports.
Assist with audits, compliance activities and quality assurance requirements.
Maintain clinical data management reports.
Review clinical trial databases and data management programs.
Respond to EDC help desk requests. Provide appropriate technical support.
Assist with project management activities and other assigned data management responsibilities.
Qualifications
Hold a bachelors degree or any similar qualification especially if it is in a science or IT subject.
An advanced degree or a relevant certificate will be a plus.
Have between one and three years of experience working in data management or a related area.
Show that you know the rules from the FDA, ICH and GCP.
Be good at using MS Office and other common computer programs.
Write English very well.
Show that you can organize things well and manage your time properly.
Be very careful with details. Make sure the data is correct.
Be able to work in clinical research teams and, with other groups of people.
Salary Structure
At Biorasi, a Senior Associate in Data Management with 1 to 3 years of experience typically earns an annual salary ranging from ₹4.8 Lakhs to ₹6.5 Lakhs, depending on prior clinical data experience and exact qualifications.
Career Development
The role provides hands-on experience in clinical data management, EDC systems, database validation, UAT, data reconciliation, and regulatory compliance.
With experience and strong technical skills, professionals can advance to Senior Data Manager, Clinical Data Manager, Lead Data Manager, or Clinical Data Management Project Manager roles.
How to Apply
Create an account on our job portal and complete your profile.
Search for the Biorasi Data Management position.
Upload your updated resume and required details.
Review your application and click Apply to submit it.
Market Insights & Trends
Salary Insights
The amount of money that gets paid can be different depending on how they have been working, where they live and what kind of job they are doing. Some places pay more than others. Most good jobs include extra money for doing a good job, health insurance and flexible hours. Companies pay high salary to make sure they can get the people they want.
Hiring Trends
The number of jobs for this profile is going up every year. Hospitals and other healthcare companies are looking for people who're good, at their job and can also figure out new problems. They want who can do the work and also think on their feet to deal with the challenges of working in healthcare today.