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1 Day ago

Business Analyst

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Pune, Maharashtra, India
Information Technology
Full-Time
Emmes

Overview

Overview

Job Posting Title

India Bengaluru

Emmes Group: Building a better future for us all.

Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.

We believe the work we do will have a direct impact on patients’ lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We’re looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!

Primary Purpose

We are looking for a motivated and detail-oriented Business Analyst to join our growing team. This role will support the requirements gathering, process improvement, documentation, and implementation of business processes and systems related to clinical trials, while ensuring compliance with key regulatory requirements such as HIPAA and 21 CFR Part 11.

Responsibilities

  • Gather, analyze, and document business and functional requirements for clinical trial processes specific to studies.
  • Collaborate with cross-functional teams including clinical operations, data management, and IT to support project execution alongside the product owner.
  • Ensure documentation and systems are compliant with HIPAA, GCP, and 21 CFR Part 11 regulations.
  • Support validation efforts in collaboration with QA for clinical trial systems and tools.
  • Create user stories, process flows, and data mapping documents to support system development and enhancements.
  • Assist stakeholders and product owners in planning and executing User Acceptance Testing (UAT).
  • Monitor updates in clinical regulations and ensure alignment with internal processes.
  • Participate in daily standups, sprint planning, and other Agile ceremonies as needed.
  • Proficient in tools such as JIRA, Confluence, MS Excel, and Visio or similar.
  • Familiarity with regulatory frameworks including HIPAA, GCP, and 21 CFR Part 11.
  • Excellent analytical, documentation, and communication skills.
  • Exposure to EDC, CTMS, or other clinical systems.
  • Experience working in Agile or hybrid SDLC environments.
  • Exposure to or understanding ophthalmology clinical studies is a plus.

Qualifications

  • Bachelor’s degree in Life Sciences, Business, Information Systems, or a related field.
  • 2+ years of experience in a Business Analyst role, preferably within clinical research or healthcare.

CONNECT WITH US!

Follow us on Twitter - @EmmesCRO

Find us on LinkedIn - Emmes

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