Hybrid Clinical Data Management Associate Jobs at Biorasi in Mumbai

Hybrid Clinical Data Management Associate Jobs at Biorasi in Mumbai

Introduction

Explore exciting opportunities as a Hybrid Clinical Data Management Associate at Biorasi, a leading full-service clinical research organization based in Mumbai. This role offers a dynamic work environment, competitive benefits, and opportunities for career growth. If you have a passion for clinical research and meet the qualifications listed below, we encourage you to apply today.

About Biorasi

Biorasi is an award-winning, customer-focused clinical research organization committed to driving new therapies to patients worldwide. We foster innovation, collaboration, and work-life balance, making Biorasi an ideal place for dedicated professionals to thrive.

Job Role: Hybrid Clinical Data Management Associate

Location

• Location: Mumbai

Responsibilities

As a Hybrid Clinical Data Management Associate at Biorasi, your responsibilities include:

• Performing data cleaning procedures and maintaining review of EDC queries.
• Developing data management listings, plans, and system validation plans.
• Ensuring compliance with 21 CFR 11 and participating in vendor data reconciliation.
• Assisting with database design, setup, and administration.
• Developing database validation specifications and User Acceptance Testing scripts.
• Preparing, collecting, and archiving study-related clinical documents and TMF activities.
• Assisting with database lock and final study reports.
• Supporting departmental audit and compliance requirements.
• Developing data management reports and programs for clinical trial data.
• Responding to EDC help desk requests and supporting Project Management as needed.
• Performing other data management duties as assigned.

Qualifications

To qualify for this position, you should have:

• Education: Bachelor’s degree or equivalent, preferably in a scientific or IT-related discipline. Advanced degree or diploma is preferred.
• Experience: 2 to 4 years of prior data management experience.
• Skills: Fluent in English (oral and written), knowledge of FDA, ICH, and GCP guidelines, proficiency in MS Office, excellent organizational skills, strong communication skills (verbal and written), and attention to detail.

How to Apply

If you have the required experience and are looking to join a dynamic and collaborative team, apply directly through Biorasi Careers or email your application to careers@biorasi.com.