Data Management Professional

2 days ago

Bengaluru, Karnataka, India beBeeClinical Full time ₹ 8,00,000 - ₹ 15,00,000
Job Description

The Senior Clinical Data Associate plays a crucial role in the clinical trial data management process from study start-up to post-database lock.

This position requires exceptional organizational and communication skills, as well as proficiency in Microsoft Office. The ideal candidate will have 5+ years of experience in clinical research and a strong understanding of ICH-GCP, relevant SOPs, and regulatory guidance.

Key Responsibilities:

  • Supporting the Lead DM as a backup and/or team member, ensuring continuity, responsiveness, and timely task completion
  • Performing data entry for paper-CRF studies, quality control of data entry, and providing input into timelines
  • Assisting in developing CRF specifications from clinical study protocols and coordinating review/feedback from stakeholders
  • Building clinical databases, conducting database build UAT, and maintaining quality-controlled database build documentation
  • Specifying requirements for edit check types, e.g., electronic, manual data review, edit checks, etc.
  • Creating, revising, appropriate versioning, and maintaining data management documentation

Additional Responsibilities:

  • Communicating with study sponsors, vendors, and project teams regarding data, databases, or other relevant project issues
  • Presenting software demonstrations/trainings, department/company training sessions, and participating in project meetings

Requirements:

  • Bachelor's degree and/or combination of related experience
  • Proficiency in Microsoft Office
  • Excellent organizational and communication skills
  • Professional use of English language
  • Basic knowledge of drug, device, and/or biologic development and effective data management practices

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