Senior Clinical Data Associate

About this job

Precision Medicine Group is hiring a Senior Clinical Data Associate to join their team in Bangalore, Karnataka. In this full-time role, you will provide data management support across all stages of clinical trials, following standard operating procedures and regulatory directives. Your daily responsibilities will include assisting with database development and testing, reviewing and querying clinical trial data, creating CRF specifications, and maintaining data management documentation. You will work closely with lead data managers, study sponsors, and third-party vendors to ensure tasks are completed on time and meet quality standards. Additionally, the role involves training clinical research personnel, conducting user acceptance testing for database builds, performing medical coding, and identifying or troubleshooting operational issues using metric data and team input. This position requires careful attention to detail, adherence to project timelines, and effective communication across various project teams and stakeholders to support successful clinical trial outcomes.

Responsibilities

• Support the Lead DM as a back-up and ensure timely task completion.
• Assist in developing CRF specifications and building clinical databases.
• Conduct database build UAT and maintain documentation.
• Review and query clinical trial data according to the Data Management Plan.
• Perform medical coding to ensure medical logic and consistency.
• Coordinate SAE and AE reconciliation.
• Train clinical research personnel on study-specific CRF and EDC items.

Requirements

• 5+ years of experience
• Bachelor's degree and/or a combination of related experience
• Proficiency in Microsoft Office applications including Word, Excel, PowerPoint, and Outlook
• Ability to handle a variety of clinical research tasks
• Excellent organizational and communication skills
• Professional use of both written and oral English
• Basic knowledge of drug, device, and/or biologic development and data management practices

Good to have

• Experience in a clinical, scientific, or healthcare discipline
• Dictionary medical coding experience using MedDRA and WHODrug
• Understanding of CDISC standards such as CDASH, SDTM, and ADaM
• Oncology and/or Orphan Drug therapeutic experience

Who should apply

This position suits experienced professionals with a background in clinical research, data management, or healthcare disciplines. Candidates must possess at least five years of relevant experience, a bachelor's degree, and strong organizational and communication skills. Applicants should have a basic understanding of drug development and data management practices, along with the ability to work independently or within a project team. As this is a senior role requiring prior experience, freshers should not apply.

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